MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-11-30 for ANGEL WNG 25GX3/4X12IN TUBING 8881225208 manufactured by Tyco/kendall Healthcare.
[776088]
It was reported to tyco-kendall healthcare on 11/09/2007, that a customer had a problem with an angel wing. The customer reports, "the nurse tried to attempt to draw blood from a patient and the needle came out of the set in the patient's arm when she withdrew the needle. "
Patient Sequence No: 1, Text Type: D, B5
[8010885]
An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2007-00039 |
| MDR Report Key | 955456 |
| Report Source | 07 |
| Date Received | 2007-11-30 |
| Date of Report | 2007-11-09 |
| Date of Event | 2007-10-09 |
| Report Date | 2007-11-09 |
| Date Reported to Mfgr | 2007-11-09 |
| Date Mfgr Received | 2007-11-09 |
| Date Added to Maude | 2008-03-11 |
| 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 | ADRIENNE MARCELLUS, RN |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618441 |
| Manufacturer G1 | TYCO HEALTHCARE/KENDALL |
| Manufacturer Street | BLVD INSURGENTES PARCELS #37 |
| Manufacturer City | TIJUANA, BC 22570 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22570 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGEL WNG 25GX3/4X12IN TUBING |
| Generic Name | ANGEL WING - BLOOD COLLECTOR |
| Product Code | GJE |
| Date Received | 2007-11-30 |
| Model Number | 8881225208 |
| Catalog Number | 8881225208 |
| Lot Number | 6258299 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 953801 |
| Manufacturer | TYCO/KENDALL HEALTHCARE |
| Manufacturer Address | BLVD INSURGENTES PARCEL TIJUANA, BC MX 22570 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-30 |