ONE WAY VALVE 001800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1999-06-18 for ONE WAY VALVE 001800 manufactured by Allegiance Healthcare Corp..

Event Text Entries

[19235086] Account states one way valve was placed in circuit backwards because there is no way to determine which way the valve should be placed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1423507-1999-00168
• MDR Report Key: 228242
• Report Source: 05
• Date Received: 1999-06-18
• Date of Report: 1999-06-18
• Date Mfgr Received: 1999-05-19
• Date Added to Maude: 1999-06-23
• 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: 0
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ONE WAY VALVE
• Generic Name: ONE WAY VALVE
• Product Code: CBP
• Date Received: 1999-06-18
• Model Number: 001800
• Catalog Number: 001800
• Lot Number: UNK
• ID Number: NA
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: N
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 221328
• Manufacturer: ALLEGIANCE HEALTHCARE CORP.
• Manufacturer Address: 1500 WAUKEGAN RD. MCGAW PARK IL 60085 US
• Baseline Brand Name: ONE WAY VALVE
• Baseline Generic Name: ONE WAY VALVE
• Baseline Model No: 001800
• Baseline Catalog No: 001800
• Baseline ID: NA
• Baseline Device Family: ACCESSORY
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K790151
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-06-18