MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-09-20 for ANG WING 23GA BCS W/BC HLDR 8881225265 manufactured by Covidien.
[17864756]
It was reported to covidien on (b)(6) 2010 that a customer had an issue with a blood collection device. Customer reports a needle stick was caused due to a flimsy safety device. The customer stated the plastic safety part is "flimsier" than the old one, the nurse did not have proper control of the unit causing her hand to slip and being stuck with the needle.
Patient Sequence No: 1, Text Type: D, B5
[17911607]
Submit date: (b)(4) 2010. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2010-00020 |
| MDR Report Key | 1850429 |
| Report Source | 06 |
| Date Received | 2010-09-20 |
| Date of Report | 2010-09-03 |
| Date of Event | 2010-09-02 |
| Report Date | 2010-09-03 |
| Date Reported to Mfgr | 2010-09-03 |
| Date Mfgr Received | 2010-09-03 |
| Date Added to Maude | 2011-02-11 |
| 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 | 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 | ANG WING 23GA BCS W/BC HLDR |
| Generic Name | BLOOD COLLECTION DRIVE |
| Product Code | GJE |
| Date Received | 2010-09-20 |
| Model Number | 8881225265 |
| Catalog Number | 8881225265 |
| Lot Number | UNK |
| 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 TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-09-20 |