ANGEL WING * 8881225240

MAUDE Adverse Event Report

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.

Event Text Entries

[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

MAUDE Entry Details

• 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

Device Details

• 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

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2005-12-21