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 2019-03-05 for ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA ABS-10062T manufactured by Arthrex, Inc..
[137838009]
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
[137838010]
It was reported during a shoulder dmc procedure the tube was cracked and leaking blood. The blood was minimal and did not come in contact with anyone's skin. However, a small amount of blood escaped outside of the tube. This was discovered before it spilled onto the floor. The device was cleaned and the kit was replaced so the procedure could be completed without additional issues.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2019-00940 |
| MDR Report Key | 8390764 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-03-05 |
| Date of Report | 2019-05-29 |
| Date of Event | 2019-02-12 |
| Date Mfgr Received | 2019-02-12 |
| Device Manufacturer Date | 2018-11-26 |
| Date Added to Maude | 2019-03-05 |
| 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 SYSTEM WITH ASPIRATION KIT W/ ACDA |
| Generic Name | PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2019-03-05 |
| Model Number | ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA |
| Catalog Number | ABS-10062T |
| Lot Number | 831788025 |
| 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 | 2019-03-05 |