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 2020-01-20 for ARTHREX ANGEL PRP KIT (US TRAY) ABS-10061T manufactured by Arthrex, Inc..
[187077381]
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
[187077382]
It was reported that during a prp injection, the abs-10061t, malfunctioned. The cassette portion of the kit broke when it started spinning and the blood drained into the machine. The facility ended up losing all the blood that was drawn but the surgeon wanted to go ahead and try again with a second kit. The second kit was successful. Additional information requested on 12/30/2019. Additional information received 12/30/2019: it was reported that during an arthroscopic meniscal repair with prp injection, the abs-10061t, malfunctioned. The cassette portion of the kit broke when it started spinning and the blood drained into the machine. The facility ended up losing all the blood that was drawn but the surgeon wanted to go ahead and try again with a second kit which was successful. It was found that blood splattered onto the surrounding walls and around the cart that the angel machine was sitting on. The rep cleaned the walls, cart, and surrounding areas with towels and cleaning solution. The rep also cleaned the blood that was in and on the angel machine with towels and cleaning solution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2020-01582 |
| MDR Report Key | 9607408 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-01-20 |
| Date of Report | 2020-01-20 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2019-12-30 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2020-01-20 |
| 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 | ARTHREX ANGEL PRP KIT (US TRAY) |
| Generic Name | PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2020-01-20 |
| Model Number | ARTHREX ANGEL PRP KIT (US TRAY) |
| Catalog Number | ABS-10061T |
| Lot Number | 918495126 |
| 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 | 2020-01-20 |