UNIVERSAL ASEPTIC TRANSFER KIT HOUSING
Report
- Report Number
- 0008031000-2025-00111
- Event Type
- Malfunction
- Date Received
- July 31, 2025
- Report Date
- October 9, 2025
- Manufacturer
- ZIMMER SURGICAL SA
- Product Code
- MOQ
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
IT HAS COME TO OUR KNOWLEDGE THAT THIS COMPLAINT IS A DUPLICATE AND OCCURRED IN FRANCE, INDEED. SECTION E HAS BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECT INFORMATION. UPON FURTHER INVESTIGATION, WE HAVE CONFIRMED THAT THIS EVENT HAS INDEED ALREADY BEEN REPORTED UNDER: MFG REF: 0008031000-2025-00014 AND 0008031000-2025-00014-1. GIVEN THIS INFORMATION THIS MDR REPORT WILL BE VOIDED.
(B)(4). G2- FOREIGN - HUNGARY. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.
IT HAS COME TO OUR KNOWLEDGE THAT THIS COMPLAINT IS A DUPLICATE AND OCCURRED IN FRANCE, INDEED. SECTION E HAS BEEN UPDATED ACCORDINGLY TO REFLECT THE CORRECT INFORMATION. UPON FURTHER INVESTIGATION, WE HAVE CONFIRMED THAT THIS EVENT HAS INDEED ALREADY BEEN REPORTED UNDER: MFG REF: 0008031000-2025-00014 AND 0008031000-2025-00014-1. GIVEN THIS INFORMATION THIS MDR REPORT WILL BE VOIDED.
IT WAS REPORTED THAT THE LOCKING MECHANISM OF HOUSING GOT BROKEN. NO CONSEQUENCES OR IMPACT TO THE PATIENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56321 | UNIVERSAL ASEPTIC TRANSFER KIT HOUSING | BATTERY, REPLACEMENT, RECHARGEABLE | MOQ | ZIMMER SURGICAL SA | 5018476 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |