MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-06-15 for GPS III PLATELET CONCENTRATE SEPARATION KIT/SINGLE DISPOSABLE 30ML ACD-A N/A 800-1003A manufactured by Biomet Biologics.
[77632595]
(b)(6). Customer has indicated that the product will not be returned [hospital retained product] to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[77632596]
It was reported that once the kit was opened for an orthobiologics procedure, the acd-a solution bottle was found to be cracked. A new bottle was available for use to complete the procedure. No patient consequences were reported as a result of the malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-03968 |
| MDR Report Key | 6642990 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-15 |
| Date of Report | 2017-09-21 |
| Date of Event | 2017-04-21 |
| Date Mfgr Received | 2017-09-21 |
| Device Manufacturer Date | 2016-07-08 |
| Date Added to Maude | 2017-06-15 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | BIOMET ORTHOPEDICS |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GPS III PLATELET CONCENTRATE SEPARATION KIT/SINGLE DISPOSABLE 30ML ACD-A |
| Generic Name | SUPPLIES, BLOOD BANK |
| Product Code | KSS |
| Date Received | 2017-06-15 |
| Model Number | N/A |
| Catalog Number | 800-1003A |
| Lot Number | 601685 |
| ID Number | NI |
| Device Expiration Date | 2019-09-30 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET BIOLOGICS |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-15 |