MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-04-04 for ANGEL WING 23G BCS W/LUER ADPTR 8881225307 manufactured by Covidien.
[21261377]
It was reported to covidien on (b)(6) 2013 that a customer had an issue with a blood collection device. The customer reports the metal needle guard popped off when the clinician moved the guard up to cap at the end of the needle after the clinician drew blood. The customer also stated that there was no medical intervention needed as a result.
Patient Sequence No: 1, Text Type: D, B5
[21270223]
(b)(4). An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2013-00008 |
| MDR Report Key | 3063935 |
| Report Source | 05,06 |
| Date Received | 2013-04-04 |
| Date of Report | 2013-03-08 |
| Report Date | 2013-03-08 |
| Date Reported to Mfgr | 2013-03-08 |
| Date Mfgr Received | 2013-03-08 |
| Date Added to Maude | 2013-06-03 |
| 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 | ASHLEY MURPHY |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616620 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 37 BLVD. INSURGENTES LIBRIAMENTO A LA P, LA MESA |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| 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 DEVICE |
| Product Code | GJE |
| Date Received | 2013-04-04 |
| Model Number | 8881225307 |
| Catalog Number | 8881225307 |
| Lot Number | 122920027 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 37 BLVD. INSURGENTES LIB TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-04-04 |