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 from a distributor report with the FDA on 2016-11-14 for RLV-2100 VACUUM RELIEF VALVE 4103202 manufactured by Quest Medical, Inc..

Event Text Entries

[59835818] There are no more devices of the same lot remaining in inventory for evaluation. 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


[59835819] The distributor reported an issue one of their customers encountered during use of the cardiopulmonary suction control device. The report stated the device was part of a "sucker line", a negative pressure line used during an ecmo procedure. The report stated that the one-way valve was stuck open, and to resolve the issue a cap was placed on the negative pressure release and another valve was placed proximal to the open valve. The report stated that blood was lost that required a blood transfusion to the patient and an acute pressure drop was observed as a result of the alleged event. The report was completed and no further patient impact was reported. The device was discarded by the end-user and not returned to the distributor or manufacturer for evaluation. The device is a cardiopulmonary suction control device sold in bulk, non-sterile form to the distributor for additional processing prior to end-use.
Patient Sequence No: 1, Text Type: D, B5


[62401064] The device was not returned to the manufacturer for evaluation. There were no more devices of the same lot remaining in inventory for evaluation. 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1649914-2016-00055
MDR Report Key6100637
Report SourceDISTRIBUTOR
Date Received2016-11-14
Date of Report2016-12-09
Date of Event2016-10-17
Date Mfgr Received2016-10-18
Device Manufacturer Date2016-01-26
Date Added to Maude2016-11-14
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 Report3

Device Details

Brand NameRLV-2100 VACUUM RELIEF VALVE
Generic NameCARDIOPULMONARY SUCTION CONTROL DEVICE
Product CodeDWD
Date Received2016-11-14
Model Number4103202
Lot Number050562
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrN
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 2016-11-14

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