BARD IRRIGATION SET * 750307

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-05-21 for BARD IRRIGATION SET * 750307 manufactured by C.r. Bard.

Event Text Entries

[16613314] Bard irrigation set defective. Entire stock of applicable lot numbers removed from hosp.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 224738
• MDR Report Key: 224738
• Date Received: 1999-05-21
• Date of Report: 1999-05-17
• Date of Event: 1999-05-14
• Date Facility Aware: 1999-05-14
• Report Date: 1999-05-17
• Date Reported to FDA: 1999-05-17
• Date Reported to Mfgr: 1999-05-17
• Date Added to Maude: 1999-05-26
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BARD IRRIGATION SET
• Generic Name: IRRIGATION SET SYRINGE
• Product Code: EYN
• Date Received: 1999-05-21
• Model Number: *
• Catalog Number: 750307
• Lot Number: 76BJ2615
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 217925
• Manufacturer: C.R. BARD
• Manufacturer Address: 8195 INDUSTRIAL BLVD. COVINGTON GA 30014 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-05-21