BARD WILLIAM HARVEY H-130 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-16 for BARD WILLIAM HARVEY H-130 * manufactured by C.r. Bard, Inc..

Event Text Entries

[20521951] The valve on one of the pump lines was not functioning, as a result some air entered the pt. Suction was switched to a different line. Appropriate de-airing procedures were carried out. Pt doing well.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 144560
• MDR Report Key: 144560
• Date Received: 1998-01-16
• Date of Report: 1997-12-10
• Date of Event: 1997-12-08
• Date Facility Aware: 1997-12-09
• Report Date: 1997-12-10
• Date Added to Maude: 1998-01-21
• 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
• 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
• Generic Name: ONE WAY VALVE - OVERPRESSURE SAFETY VALVE
• Product Code: MNJ
• Date Received: 1998-01-16
• Model Number: WILLIAM HARVEY H-130
• Catalog Number: *
• Lot Number: 43H9V106
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 140948
• Manufacturer: C.R. BARD, INC.
• Manufacturer Address: 129 CONCORD RD BILLERICA MA 01821 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	1. Required No Informationntervention	1998-01-16