MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-07 for ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA ABS-10062T manufactured by Arthrex, Inc..
[126506717]
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation. Per customer, the device will not be returned. 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
[126506718]
It was reported that one of the lines on the abs-10062t, angel system aspiration kit was leaking during a bmac procedure. The rep confirmed that the blood leaked on the outside of the machine only, and did not come into contact with the patient or any surgical staff. A second abs-10062t (lot unknown) was opened and the procedure was completed successfully. The rep stated that the spilled blood was cleaned with alcohol wipes and proteolytic spray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220246-2018-00728 |
| MDR Report Key | 8047288 |
| Date Received | 2018-11-07 |
| Date of Report | 2018-11-07 |
| Date of Event | 2018-10-02 |
| Date Mfgr Received | 2018-10-15 |
| Device Manufacturer Date | 2018-08-21 |
| Date Added to Maude | 2018-11-07 |
| 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 SYSTEM WITH ASPIRATION KIT W/ ACDA |
| Generic Name | PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING |
| Product Code | ORG |
| Date Received | 2018-11-07 |
| Model Number | ANGEL SYSTEM WITH ASPIRATION KIT W/ ACDA |
| Catalog Number | ABS-10062T |
| Lot Number | 821985376 |
| 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 | 2018-11-07 |