MAUDE Adverse Event Report: QUEST MEDICAL, INC. RLV2100-B VACUUM RELIEF VALVE; CPBP SUCTION CONTROL

Model Number 4103202

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2015

Event Type  Injury  

Event Description

The device distributor reported an issue was encountered by their customer when using the (b)(4).The device is a valve sold in non-sterile form to that distributor who further processes it as part of a custom perfusion pack.It was reported that valve functioned as expected until the end of the case when it began to leak.The report stated that during this time, the product was being used at low rpms with no visible cracks noted.The perfusionist noted the rubber fitting that covers two small holes, just below the vacuum relief arm, slipped down and was not secured.The report stated it appeared blood may have leaked out of the two holes that are normally covered by the rubber ring on the valve.The device was used to complete the case but was discarded and not returned to the manufacturer for analysis.There was no patient information provided.

Manufacturer Narrative

Quest medical, inc.Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.Quest medical, inc.Defers to the patient's physician regarding medical history.

Manufacturer Narrative

The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.

• Brand Name: RLV2100-B VACUUM RELIEF VALVE
• Type of Device: CPBP SUCTION CONTROL
• Manufacturer (Section D): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer (Section G): QUEST MEDICAL, INC.; one allentown parkway; allen TX 75002
• Manufacturer Contact: amy clendening-wheeler ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 4521585
• MDR Text Key: 5541479
• Report Number: 1649914-2015-00007
• Device Sequence Number: 1
• Product Code: DWD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K864503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 4103202
• Device Lot Number: 046609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention