MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-11-21 for ANGEL WING 23GX3 / 4X12IN TUBING 8881225190 manufactured by Tyco Healthcare / Kendall.
[556821]
It was reported to tyco healthcare/kendall that a customer had a problem with an angel wing. The customer stated that the needle separated from the hub and remained in the pt. She was able to remove the needle because? Inch of the needle was sticking out.
Patient Sequence No: 1, Text Type: D, B5
[7985687]
An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2006-00057 |
| MDR Report Key | 788752 |
| Report Source | 06 |
| Date Received | 2006-11-21 |
| Date of Report | 2006-11-16 |
| Date Reported to Mfgr | 2006-11-16 |
| Date Mfgr Received | 2006-11-16 |
| Date Added to Maude | 2006-12-04 |
| 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 | TYCO HEALTHCARE / KENDALL |
| Manufacturer Street | FABRICA BLVD. INSURGENTES |
| Manufacturer City | LA MESA, TIJUANA * * |
| Manufacturer Country | MX |
| Manufacturer Postal Code | * |
| 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 BLOOD COLLECTION DEVICE |
| Product Code | GJE |
| Date Received | 2006-11-21 |
| Model Number | 8881225190 |
| Catalog Number | 8881225190 |
| Lot Number | 5322371 |
| ID Number | * |
| Operator | UNKNOWN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 776445 |
| Manufacturer | TYCO HEALTHCARE / KENDALL |
| Manufacturer Address | FABRICA BLVD INSURGENTES TIJUANA MX |
| Baseline Brand Name | MONOJECT |
| Baseline Generic Name | BLOOD COLLECTION SET |
| Baseline Model No | 8881225190 |
| 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 | 2006-11-21 |