MAUDE Adverse Event Report: QUEST MEDICAL, INC RLV-2100 VACUUM RELIEF VALVE; CARDIOPULMONARY SUCTION CONTROL DEVICE

Model Number 4103202

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was discarded by the user and could therefore not be evaluated.A dhr review could not be completed as no lot number was provided.

Event Description

The report received states that the device leaked during a procedure.

• Brand Name: RLV-2100 VACUUM RELIEF VALVE
• Type of Device: CARDIOPULMONARY SUCTION CONTROL DEVICE
• 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: tosan onosode ; one allentown parkway; allen, TX 75002 ; 9723326338
• MDR Report Key: 9359228
• MDR Text Key: 167920201
• Report Number: 1649914-2019-00062
• Device Sequence Number: 1
• Product Code: DWD
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K864503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 4103202
• Device Catalogue Number: 4103202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/18/2019
• Initial Date FDA Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1