RLV 2100 "B" SUCTION CONTROL DEVICE 4103102

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2016-01-21 for RLV 2100 "B" SUCTION CONTROL DEVICE 4103102 manufactured by Quest Medical, Inc..

Event Text Entries

[36492263] The reported complaint condition could not be confirmed. The sample (lot unknown) was attached to a roller pump and ran at both low and high speeds. No leaks were observed. The testing was repeated at various pressures as well. The device continued to perform as expected.
Patient Sequence No: 1, Text Type: N, H10


[36492264] The international distributor ((b)(4)) reported an issue encountered with the suction control device during use. They stated their customer reported that during a procedure in (b)(6) 2015, when blood flowed through the pressure relief valve case, blood was observed to be leaking from it. They said approximately 10 mls of blood leaked before it was noticed. It was replaced by another valve and the procedure resumed with no danger to patient. The device lot number was not recorded or provided. The device was returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1649914-2015-00121
MDR Report Key5382692
Report SourceDISTRIBUTOR,FOREIGN
Date Received2016-01-21
Date of Report2015-11-20
Date of Event2015-07-01
Date Mfgr Received2015-11-20
Date Added to Maude2016-01-21
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 "B" SUCTION CONTROL DEVICE
Generic NameCARDIOVASCULAR SUCTION CONTROL DEVICE
Product CodeDWD
Date Received2016-01-21
Returned To Mfg2015-12-01
Model Number4103102
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 2016-01-21

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