MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-04-15 for ANGEL WING 23G BCS W/LUER ADPTR 8881225307 manufactured by Covidien.
[1168917]
It was reported to covidien on 04/02/2009 that a customer had an issue with a blood collection needle. Customer reports that they received one package that contained two angle wing devices. One of the devices appeared damaged and the needle had been broken in half.
Patient Sequence No: 1, Text Type: D, B5
[8436406]
(b) (4). A investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2009-00016 |
| MDR Report Key | 1419677 |
| Report Source | 06 |
| Date Received | 2009-04-15 |
| Date of Report | 2009-04-02 |
| Report Date | 2009-04-02 |
| Date Reported to Mfgr | 2009-04-02 |
| Date Mfgr Received | 2009-04-02 |
| Date Added to Maude | 2010-02-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | ELAINE BISHOP |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524686 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 2498 ROLL DRIVE #727 |
| Manufacturer City | SAN DIEGO CA 92154 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92154 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGEL WING 23G BCS W/LUER ADPTR |
| Generic Name | BLOOD COLLECTION NEEDLE |
| Product Code | GJE |
| Date Received | 2009-04-15 |
| Model Number | 8881225307 |
| Catalog Number | 8881225307 |
| Lot Number | 8165232 |
| ID Number | NA |
| Operator | OTHER |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2498 ROLL DR #727 SAN DIEGO CA 92154 US 92154 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-04-15 |