MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-12-21 for ANGEL WING * 8881225240 manufactured by Kendall Healthcare.
[415295]
While disconnecting syringe from blood culture tube with angel wing: needle inside angel wing came out with syringe and scraped finger.
Patient Sequence No: 1, Text Type: D, B5
Report Number | MW1037251 |
MDR Report Key | 655807 |
Date Received | 2005-12-21 |
Date of Report | 2005-12-09 |
Date of Event | 2005-12-06 |
Date Added to Maude | 2005-12-27 |
Event Key | 0 |
Report Source Code | Voluntary report |
Manufacturer Link | N |
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 | 0 |
Report to FDA | 0 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ANGEL WING |
Generic Name | BLOOD TRANSFER DEVICE |
Product Code | GJE |
Date Received | 2005-12-21 |
Returned To Mfg | 2005-12-08 |
Model Number | * |
Catalog Number | 8881225240 |
Lot Number | 5266355 |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 645295 |
Manufacturer | KENDALL HEALTHCARE |
Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02049 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 | 1. Required No Informationntervention | 2005-12-21 |