MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2006-01-12 for TRNSFR SET-FEMALE (BLOOD CULT) 8881225240 manufactured by Tyco/kendall Healthcare.
[439916]
The customer alleges that in 2005 "while disconnecting the syringe from the blood culture tube with angel wing, the needle inside the angel wing came out and scraped the finger of the nurse. " the customer alleges "the contaminated needle broke the skin of the nurse. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2006-00003 |
| MDR Report Key | 665281 |
| Report Source | 05,06,07 |
| Date Received | 2006-01-12 |
| Date of Report | 2006-01-04 |
| Date of Event | 2005-12-06 |
| Date Reported to Mfgr | 2006-01-04 |
| Date Mfgr Received | 2006-01-04 |
| Date Added to Maude | 2006-01-20 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ADRIENNE MARCELLUS, RN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618441 |
| Manufacturer G1 | TYCO/KENDALL HEALTHCARE |
| Manufacturer Street | 2498 ROLL DRIVE #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 | TRNSFR SET-FEMALE (BLOOD CULT) |
| Generic Name | ANGEL WING BLOOD TRANSFER DEVICE |
| Product Code | GJE |
| Date Received | 2006-01-12 |
| Model Number | 8881225240 |
| Catalog Number | 8881225240 |
| Lot Number | 5266355 |
| 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 | 645295 |
| Manufacturer | TYCO/KENDALL HEALTHCARE |
| Manufacturer Address | 2498 ROLL DRIVE #727 SAN DIEGO CA 92154 US |
| Baseline Brand Name | MONOJECT |
| Baseline Generic Name | BLOOD COLLECTION SET |
| Baseline Model No | 8881225240 |
| 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 | 2006-01-12 |