MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-05-31 for ARTHREX ANGEL PRP KIT (US TRAY) ABS-10061T manufactured by Arthrex, Inc..
[146658303]
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. The device was reported to have been discarded. The root cause of the event could not be determined from the information available and without device evaluation.
Patient Sequence No: 1, Text Type: N, H10
[146658304]
It was reported during an in-clinic hair regeneration procedure, as the abs-10061t angel prp kit was spinning, blood started leaking outside of the tube right at the knob where the tube is winded. The facility reporter stated that the blood remained on the machine itself and did not leak onto the table or floor. Once the blood was noticed, the staff stopped the machine and opened a second kit from the same lot. The doctor re-drew blood and the case was completed without further issue. The blood was cleaned with cavi wipes. The kit was discarded and will not be returning.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2019-01127 |
| MDR Report Key | 8658390 |
| Report Source | USER FACILITY |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-03-16 |
| Date Mfgr Received | 2019-05-09 |
| Date Added to Maude | 2019-05-31 |
| 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 | ARTHREX ANGEL PRP KIT (US TRAY) |
| Generic Name | PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2019-05-31 |
| Model Number | ARTHREX ANGEL PRP KIT (US TRAY) |
| Catalog Number | ABS-10061T |
| Lot Number | UNK |
| 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 | 2019-05-31 |