N
Patient 1
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DISCARDED.
MAUDE MDR 7515685
- MDR report key
- 7515685
- Report number
- 0001825034-2018-03368
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-04-18
- Date received
- 2018-05-15
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. CHRISTINA ARNT
- Address
- 56 E. BELL DR. WARSAW IN 46582 US
- Phone
- 574-574-5745
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PLASMAX MINI KIT W/30ML ACDA | SUPPLIES, BLOOD-BANK | ZIMMER BIOMET, INC. | KSS | N/A | 800-0516 | NI | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-05-15 | 0 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE TIP OF THE SYRINGE BROKE OFF INTO THE PLASMAX TUBE. THE DEFECTIVE TUBE WAS THROWN AWAY IN BIOHAZARD. THERE WAS A 20 MINUTE DELAY BECAUSE THE PATIENT?S BLOOD HAD TO BE REDRAWN. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.
N
Patient 1
THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. PRODUCT NOT RETURNED.
D
Patient 1
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.