Terumo Employees Confirm FDA Report that Terumo Allows Defective Angio-Seals to Enter the Marketplace
I previously wrote about the FDA issuing a report in August 2022 saying that Terumo Medical Corporation, a Japanese medical device manufacturer with distribution in 160 countries, failed to segregate defective Angio-Seals before distribution in the world-wide marketplace. Angio-Seals are used by doctors in various medical procedures, such as TAVRs, to close openings they made in arteries as part of the medical procedure. FDA reported that Terumo only segregated identified defective Angio-Seals if it was convenient.
Now FDA has issued another report in July 2024 identifying additional deficiencies in the Terumo quality control procedures. For example it says Terumo only measures the critical weight of certain Angio-Seal components once per year, so deviations from the critical weight can occur, causing the Angio-Seal to be incapable of performing its intended function. FDA notes other deficiencies in Terumo’s Quality Control procedures.
One or more employees in Terumo’s Quality Control division read my original Substack post about the original FDA Report, and he/they sent me an exhaustive article detailing many deficiencies in Terumo’s Quality Control procedures.
I am here including the entirety of the Terumo employees statement about significant deficiencies in Terumo’s Quality control procedures in its Caguas, Puerto Rico facility being the sole world-wide source of Angio-Seals. I have already provided the employee statement to the FDA. The Terumo employee statement:
Terumo Quality Information
Dear Mr. Harold. I am an employee of Terumo in Caguas, Puerto Rico and I am well aware of the quality control deficiencies that have existed at that plant for over 20 years. At that plant, the actual general manager named Rafael Benitez is a kind of mafia boss who allows these deviations to occur in order to reduce operational costs and his trusted employees are his accomplices. Investigate why Mr. Benitez only hires people he trusts and is loyal to him "LÓPEZ HERNÁNDEZ v. Terumo Medical Devices Company". He also hires quality engineers with no experience whatsoever, recently graduated, to adapt them to his irregularities... The supervisors in the process areas know what is going on, but these are Mr. Rafael Benitez's corrupt and loyal soldiers. Some of these supervisors do not have the experience, education or competence to carry out these responsible roles. In the document I just read, you mention that people have possibly died and this is terrible. I am very sorry. Terumo management outside of Puerto Rico is aware that these deviations have always occurred but for reasons we do not understand, they have covered them up. The employees at the plant work in fear and those who have reported these deviations have been harassed, persecuted and even fired. Let us hope that justice is done. I thank God that I stumbled upon this article of yours and I am glad that you are well and have survived using a faulty device. Inform the FDA to investigate transactions in the plant's document and inventory systems (MES and SAP) and there they will find evidence of shady handling to approve and ship contaminated and defective batches. Specifically, look for transactions of movements to Quarantine of the user Tammy Estrada (Years 2020 y 2021). These Quarantine to Approval transactions were executed without the required investigations. Please write more articles about this so that patients are not at risk by using this device that is manufactured without adequate quality controls. At the approximate dates of the manufacture of the batch that caused your damage, there was a huge incidence of batches with many defects in the plant, such as: 1. Batches with anchor and collagen defects due to the manufacturing process carried out quickly and without knowledge by personnel hired on a third shift without appropriate training and in turn being directed by supervisors and group leaders who unscrupulously gave instructions to repair parts improperly and violating procedures to reduce waste of materials and reduce costs. 2. Batches contaminated with metal particulate. 3. Batches contaminated with dirty oil from the machines. 4. Batches with parts that had serious defects from the molding process. 5. Batches that used expired suture. 6. Batches with mixtures of components. 7. Batches with reconciliation problems because parts with defects and parts without defects were mixed. 8.The warehouse personnel in charge of inventory and shipping have an impressive record of errors. These warehouse personnel at this plant are not trained nor do they understand how inventory and shipping should be handled in a regulated industry. To corroborate this information, investigate the inexplicable inventory adjustments due to the product mixes that they make. 9. When the machinery breaks down, the mechanics in charge are unscrupulous and in many critical cases do not document the corrective measures that should be documented and carry out the repairs without the required aseptic handling. 10. At one stage of the process, one of the critical parts of the device (Sheath) was exposed to the environment for 24 hours with a lubricating chemical. On many occasions the plant's utility personnel performed repairs on the roofs and the parts became covered in particulate and dirt. These dirty parts (thousands of them) were shipped in the Sheath Kits. In this particular case some honest employees reported the situation and investigations had to be conducted. I believe the employees who reported this incident were fired. There were many more defects with batches that were all shipped. All cases are well known to management and investigations were practically not carried out. They began to document some investigations when some honest employees insisted on the seriousness of the defects. Prior to 2020, investigations into defects were practically never documented, giving the false impression that everything was perfect. Additionally, the validation processes for machinery and component suppliers occur irregularly. These processes occur by documenting processes that supposedly occur satisfactorily when in reality this is not the case. An example of this was that when Terumo acquired Angioseal, the suppliers of most of the components changed to a supplier belonging to Terumo and the new materials arrived defective. The validation processes for these new components also happened to occur on the manufacturing dates of the damaged device that they used with you. Lives must be saved... Oct 20 5:52 PM Terumo Quality Information
This statement from Terumo Quality Information was filed with the Court in my case of Harold Berk v. Terumo Medical Corporation, No: 23-cv-10-JLH as document 104-2.
