MAUDE Adverse Event Report: QUEST MEDICAL, INC. VACUUM RELIEF VALVE II-C; CPBP SUCTION CONTROL, INTRACARDIAC

Model Number 4004203

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 04/07/2014

Event Type  Injury  

Event Description

The foreign dist (b)(6) notified the mfr of an issue encountered with the vrv-iic vacuum relief valve.The distributor reported that their customer (hosp) encountered a leak during a procedure using the valve.They reported an approximate 50-100ml pt blood loss as a result of the alleged event.There was no other pt impact reported.The hosp personnel removed the valve and completed the procedure successfully.The device was returned to the mfr for analysis.

Manufacturer Narrative

(b)(4).Device evaluation.Device history record review and additional device analysis are still underway to investigate the source of the alleged leak.Quest medical, inc.Has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Quest medical, inc defers to the pt's physician regarding medical history.

• Brand Name: VACUUM RELIEF VALVE II-C
• Type of Device: CPBP SUCTION CONTROL, INTRACARDIAC
• Manufacturer (Section D): QUEST MEDICAL, INC.; allen TX
• Manufacturer Contact: amy clendening-wheeler ; one allentown pkwy.; allen, TX 75002 ; 9723326338
• MDR Report Key: 3812642
• MDR Text Key: 16600520
• Report Number: 1649914-2014-00020
• Device Sequence Number: 1
• Product Code: DWD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K760894
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4004203
• Device Lot Number: 045395
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/24/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention