BARD OPS VALVE H130

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,08 report with the FDA on 1999-06-23 for BARD OPS VALVE H130 manufactured by Bard Vascular System.

Event Text Entries

[156739] The ops valve failed to 'relieve' during the case causing a significant amount of air to be introduced into the pt's heart. As a result, the pt was on bypass an additional 20mins. To de-air the heart. The pt's aorta was cross-clamped at the time. No pt injury occurred as a result of this event.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1222008-1999-00021
• MDR Report Key: 230080
• Report Source: 05,06,07,08
• Date Received: 1999-06-23
• Date of Report: 1999-06-08
• Report Date: 1999-06-08
• Date Reported to FDA: 1999-06-21
• Date Mfgr Received: 1999-06-08
• Date Added to Maude: 1999-07-07
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BARD OPS VALVE
• Generic Name: OVERPRESSURE SAFETY VALV
• Product Code: MNJ
• Date Received: 1999-06-23
• Model Number: NA
• Catalog Number: H130
• Lot Number: UNK
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: UNKNOWN
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 223141
• Manufacturer: BARD VASCULAR SYSTEM
• Manufacturer Address: LAS PIEDRAS IND.PK LOT #5 LAS PIEDRAS PR 00771 US
• Baseline Brand Name: OVERPRESSURE SAFETY VALVE
• Baseline Generic Name: OPS VALVE
• Baseline Model No: NA
• Baseline Catalog No: H130
• Baseline ID: NA

Patients

Patient Number	Treatment	Outcome	Date
1	0		1999-06-23