MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-07-20 for ANGEL WING 23GX3 / 4X12IN TUBING 8881225190 manufactured by Covidien.
[622833]
It was reported to covidien that a customer had a problem with an angel wing. The customer stated that the needle separated from the hub and remained in the pts arm. The needle was able to be removed from the pts arm.
Patient Sequence No: 1, Text Type: D, B5
[7904883]
An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2007-00023 |
| MDR Report Key | 882478 |
| Report Source | 06 |
| Date Received | 2007-07-20 |
| Date of Report | 2007-07-17 |
| Date of Event | 2007-07-10 |
| Date Reported to Mfgr | 2007-07-17 |
| Date Mfgr Received | 2007-07-17 |
| Date Added to Maude | 2007-08-20 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616625 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | FABRICA BLVD INSURGENTES 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 23GX3 / 4X12IN TUBING |
| Generic Name | ANGEL WING COLLECTION DEVICE |
| Product Code | GJE |
| Date Received | 2007-07-20 |
| Model Number | 8881225190 |
| Catalog Number | 8881225190 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 874787 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | FABRICA BLVD INSURGENTES TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-20 |