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

Model Number 4103202

Device Problems Leak/Splash (1354); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device will be evaluated when it is received. A follow up medwatch will be submitted if additional information becomes available. The event occurred in an ous country. The device is sold bulk non-sterile to oem manufacturers. This medwatch has been submitted because a similar device is marketed by quest medical in the us.

Event Description

A report received from a customer states that the plastic collar slipped off and was leaking under no pressure. There were no patient complications.

• 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: 9678603
• MDR Text Key: 190529391
• Report Number: 1649914-2020-00006
• Device Sequence Number: 1
• Product Code: DWD
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K864503
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 4103202
• Device Catalogue Number: 4103202
• Device Lot Number: 056972
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/08/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unkown