RLV-2100 VACUUM RELIEF VALVE 4103202

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-29 for RLV-2100 VACUUM RELIEF VALVE 4103202 manufactured by Quest Medical, Inc..

Event Text Entries

[71207774] 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. 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.
Patient Sequence No: 1, Text Type: N, H10


[71207775] The distributor reported an issue one of their customers encountered during use of the cardiopulmonary suction control device. The report stated the device leaked in the white line of the distributor's custom perfusion pack. The report stated the leak was monitored and the procedure successfully completed with no complications. There were no patient complications reported as a result of the alleged event. The distributor's performance analysis stated their analysis of the device found it leaked at approximately 400 mmhg instead of the specified 1300 mmhg. The device is a cardiopulmonary suction control device sold in bulk, non-sterile form to the distributor for additional processing prior to end-use. The device was returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1649914-2017-00021
MDR Report Key6445076
Date Received2017-03-29
Date of Report2017-02-27
Date of Event2017-02-24
Date Mfgr Received2017-02-27
Device Manufacturer Date2016-01-27
Date Added to Maude2017-03-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. AMY CLENDENING-WHEELER
Manufacturer StreetONE ALLENTOWN PARKWAY
Manufacturer CityALLEN TX 75002
Manufacturer CountryUS
Manufacturer Postal75002
Manufacturer Phone9723326338
Manufacturer G1QUEST MEDICAL, INC.
Manufacturer StreetONE ALLENTOWN PARKWAY
Manufacturer CityALLEN TX 75002
Manufacturer CountryUS
Manufacturer Postal Code75002
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameRLV-2100 VACUUM RELIEF VALVE
Generic NameCARDIOPULMONARY SUCTION CONTROL DEVICE
Product CodeDWD
Date Received2017-03-29
Returned To Mfg2017-02-28
Model Number4103202
Lot Number050538
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerQUEST MEDICAL, INC.
Manufacturer AddressONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2017-03-29

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