MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-02-27 for ANGEL WING 23G BCS W/LUER ADPTR 8881225307 manufactured by Tyco/kendall Healthcare.
[403693]
It was reported to tyco/kendall healthcare that a customer had a problem with the angel wing blood collection system. The customer states that the needle came disconnected from the hub and remained stuck in the vein of the pt. They were able to remove the needle from the pt. Samples are being returned for examination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2006-00011 |
| MDR Report Key | 680866 |
| Report Source | 06 |
| Date Received | 2006-02-27 |
| Date of Report | 2006-02-21 |
| Date of Event | 2006-01-27 |
| Date Reported to Mfgr | 2006-02-21 |
| Date Mfgr Received | 2006-02-21 |
| Date Added to Maude | 2006-03-03 |
| 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 | 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/KENDALL HEALTHCARE |
| Manufacturer Street | 2498 ROLL DR #727 |
| Manufacturer City | SAN DIEGO CA 92154 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92154 |
| 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 |
| Product Code | GJE |
| Date Received | 2006-02-27 |
| Model Number | 8881225307 |
| Catalog Number | 8881225307 |
| Lot Number | 5315528 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 670137 |
| Manufacturer | TYCO/KENDALL HEALTHCARE |
| Manufacturer Address | 2498 ROLL DR # 727 SAN DIEGO CA 92154 US |
| Baseline Brand Name | MONOJECT |
| Baseline Generic Name | BLOOD COLLECTION SET |
| Baseline Model No | 8881225307 |
| 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 | 2006-02-27 |