MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-12-20 for ANGEL CPRP PROCESSING SET US ABS-10063 manufactured by Arthrex, Inc..
[131012426]
The contribution of the device to the reported event could not be determined as it was reported that the device would not be returned for evaluation. The cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[131012427]
It was reported that the plastic on the abs-10063, angel processing set (lot: 2018030113) broke during centrifugation (preparation) and leaked all over the inside of the abs-10060r, refurbished arthrex angel centrifuge. The rep stated this occurred about 15 minutes in. The rep confirmed that the some blood did leak outside of the machine. The surface with spilled blood was cleaned up with caviwipes and 70% alcohol. The blood pooled in the centrifuge and paper towels were used to get a potion of it out. The rep reported that blood draw was repeated and a new abs-10063 was used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2018-00813 |
| MDR Report Key | 8184324 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-12-20 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-12-03 |
| Date Mfgr Received | 2018-12-03 |
| Device Manufacturer Date | 2018-06-27 |
| Date Added to Maude | 2018-12-20 |
| 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 | VIK BAJNATH |
| Manufacturer Phone | 8009337001 |
| Manufacturer G1 | ARTHREX, INC. |
| Manufacturer Street | 1370 CREEKSIDE BOULEVARD |
| Manufacturer City | NAPLES FL 341081945 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 341081945 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGEL CPRP PROCESSING SET US |
| Generic Name | PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2018-12-20 |
| Model Number | ANGEL CPRP PROCESSING SET US |
| Catalog Number | ABS-10063 |
| Lot Number | 2018030113 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTHREX, INC. |
| Manufacturer Address | 1370 CREEKSIDE BOULEVARD NAPLES FL 341081945 US 341081945 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-20 |