MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-05-19 for ANGEL WING 21GX3/4X12IN TUBING 8881225182 manufactured by Tyco Healthcare/kendall.
[471229]
A customer had a problem with an angel wing blood collection needle. The customer stated that on placement of the needle into the vein, the needle completely detached from the butterfly. Only a small portion of the needle was protruding from the vein and staff were able to grasp and remove it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2006-00021 |
| MDR Report Key | 717759 |
| Report Source | 05,06 |
| Date Received | 2006-05-19 |
| Date of Report | 2006-05-17 |
| Date of Event | 2006-05-16 |
| Date Reported to Mfgr | 2006-05-18 |
| Date Mfgr Received | 2006-05-18 |
| Date Added to Maude | 2006-05-24 |
| 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 STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616625 |
| Manufacturer G1 | TYCO HEALTHCARE/KENDALL |
| Manufacturer Street | FABRICA BLVD INSURGENTES |
| Manufacturer City | LA MESA, TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ANGEL WING 21GX3/4X12IN TUBING |
| Generic Name | ANGLE WING BLOOD COLLECTION DEVICE |
| Product Code | GJE |
| Date Received | 2006-05-19 |
| Model Number | 8881225182 |
| Catalog Number | 8881225182 |
| Lot Number | 5336058 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 706826 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | FABRICA BLVD INSURGENTES TIJUANA MX |
| Baseline Brand Name | MONOJECT |
| Baseline Generic Name | BLOOD COLLECTION SET |
| Baseline Model No | 8881225182 |
| Baseline Device Family | SAFETY BLOOD COLLECTION SETS AND ACCESSORIES |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K940961 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-19 |