MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-02 for ANGEL CPRP PROCESSING SET US ABS-10063 manufactured by Arthrex, Inc..
[131894383]
The contribution of the device to the reported event could not be determined. Per the customer the device will 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
[131894384]
It was reported that after 180cc blood was taken, the surgeon started the spin and walked away. Upon return for the sample, the surgeon noticed a leak coming from the tubing where the tubing meets the light sensor block. The rep stated that there was blood on the counter, and the injection could not be completed. The procedure was not completed, and was rescheduled. Additional information requested. Additional information received on (b)(6) 2019: the rep confirmed that no individual (surgical staff nor the patient) came into contact with the blood. The staff wore gloves and appropriate ppe when cleaning the spill the machine was cleaned with virox wipes and clorox, and everything was disposed of properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2019-00830 |
| MDR Report Key | 8209431 |
| Date Received | 2019-01-02 |
| Date of Report | 2019-01-02 |
| Date of Event | 2018-10-31 |
| Date Mfgr Received | 2018-12-13 |
| Device Manufacturer Date | 2017-08-16 |
| Date Added to Maude | 2019-01-02 |
| 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 | 0 |
| Brand Name | ANGEL CPRP PROCESSING SET US |
| Generic Name | PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2019-01-02 |
| Model Number | ANGEL CPRP PROCESSING SET US |
| Catalog Number | ABS-10063 |
| Lot Number | 2017060022 |
| 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 | 2019-01-02 |