MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-07-28 for ANGEL WING 23G BCS W/ LUER ADPTR 8881225307 manufactured by Covidien.
[17292570]
It was reported to covidien on (b)(4) 2014 that a customer had an issue with a blood collection set. The customer reports the safety cover did not activate as expected. When pulling back the wings the cover does not activate.
Patient Sequence No: 1, Text Type: D, B5
[17457890]
An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2014-00044 |
| MDR Report Key | 4120816 |
| Report Source | 01,05,06 |
| Date Received | 2014-07-28 |
| Date of Report | 2014-07-01 |
| Date of Event | 2014-07-01 |
| Date Mfgr Received | 2014-07-01 |
| Date Added to Maude | 2014-10-06 |
| 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 | 0 |
| 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 | ANGEL WING 23G BCS W/ LUER ADPTR |
| Generic Name | BLOOD COLLECTION SET |
| Product Code | GJE |
| Date Received | 2014-07-28 |
| Model Number | 8881225307 |
| Catalog Number | 8881225307 |
| Lot Number | 140450242X |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 37 BLVD. INSURGENTES LI TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-28 |