BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIFURCATED EXTENSION SET

    MDR report key: 14346011 · Received May 10, 2022

    Report

    Report Number
    2245270-2022-00028
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    April 22, 2022
    Report Date
    August 29, 2022
    Manufacturer
    VYGON USA
    Product Code
    FPA
    PMA / PMN Number
    K021395
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MALFUCTIONING SAMPLE WILL BE RETURNED TO VYGON FOR DEVICE EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE SENT TO FDA WITIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 0

    THE SUPPLIER WAS CONTACTED FOR ROOT CAUSE ANALYSIS OF THE ISSUE. ONE SAMPLE WAS SENT, AND A PRODUCT INVESTIGATION WAS ALSO COMPLETED BY THE SUPPLIER. THE SUPPLIER REPORTED THE FOLLOWING: ONE (1) 69224421 FILTER, LOT NUMBER: 13387451, 13484605, 13487446, 13505059 OR 13505064 WAS RETURNED TO OUR SCIENTIFIC AND LABORATORY SERVICES (SLS) LABORATORY FOR INITIAL EVALUATION. VISUAL EXAMINATION OF THE RETURNED MIV FILTER REVEALED NO CRACKS OR ABNORMALITIES ON THE HOUSING OF THE FILTER. NO DISCOLORATION WAS OBSERVED OF THE FILTRATION MEMBRANE OR VENT MEDIA. THE RETURNED MIV FILTER WAS CUT FROM THE CUSTOMER SET PRIOR TO ETO STERILIZATION. AFTER STERILIZATION, THE RETURNED MIV FILTER WAS PRIMED WITH SALINE UNDER 1 METER GRAVITY HEAD HEIGHT AND ALLOWED TO FLUSH FOR 5 MINUTES. DURING FLUSHING, LEAKAGE WAS OBSERVED FROM THE VENT AFTER APPROXIMATELY 2 MINUTES. THE FILTER WAS THEN SUBJECTED TO A TREATMENT THAT MAY FULLY OR PARTIALLY RESTORE THE HYDROPHOBIC PROPERTIES OF VENTS THAT HAVE BECOME TEMPORARILY COMPROMISED DUE TO SATURATION BY LOW SURFACE TENSION END USE SOLUTIONS OR POTENTIALLY FROM TUBE BONDING SOLVENTS DURING SET ASSEMBLY. AFTER DRYING THE RETURNED MIV FILTER WAS PRIMED WITH SALINE UNDER 1-METRE GRAVITY HEAD HEIGHT. NO LEAKAGE WAS OBSERVED FROM THE VENT DURING PRIMING OR INITIAL FLOW. PRESSURE HOLD TESTING WAS THEN PERFORMED AT 29 PSI FOR 15 MINUTES WHICH SUBSEQUENTLY PASSED INDICATING THE HYDROPHOBICITY OF THE VENT WAS AT LEAST PARTIALLY RESTORED. ALL MIV FILTER LOTS ARE ASSEMBLED WITH VALIDATED PROCESS PARAMETERS AND WITH MATERIALS BELIEVED SUITABLE TO THEIR INTENDED END USE, AND SUCCESSFULLY MEET STRINGENT IN-PROCESS TESTING PRIOR TO BEING RELEASED TO INVENTORY. WE DID A REVIEW OF THE MANUFACTURING BATCH RECORDS FOR THE IMPLICATED LOT NUMBERS REFERENCED ABOVE. IT CONFIRMED THAT THE LOTS WERE MANUFACTURED ACCORDING TO APPROVED PROCEDURES AND MET ALL SPECIFICATIONS FOR RELEASE, WITH NO NOTED MANUFACTURING DEVIATIONS, NCE'S OR CAPAS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED VENT LEAK CONCERN. WITH THE TEST RESULTS FROM PALL SLS SUPPORTING THAT THE VENTS HYDROPHOBIC PROPERTIES WERE TEMPORARILY COMPROMISED THE DETERMINED ROOT CAUSE WAS "COULD NOT DETERMINE ROOT CAUSE". POTENTIAL SCENARIOS EXIST WHERE THE VENT'S HYDROPHOBIC PROPERTIES MAY BECOME TEMPORARILY COMPROMISED OR WEAKENED FROM TREATMENTS AND EXPOSURES THAT OCCUR AFTER FILTER ASSEMBLY THAT MAY RESULT IN FLUID LEAKAGE THROUGH THE VENT, PARTICULARLY WITH LOWER SURFACE TENSION FLUIDS THAT MAY CONTAIN ELEMENTS OF ALCOHOL OR LIPIDS. CUSTOMER AWARENESS REGARDING THE POTENTIAL ADVERSE EFFECTS ON VENT FUNCTIONALITY FROM POST FILTER ASSEMBLY TREATMENTS AND EXPOSURES IS INTENDED. A REVIEW OF THE HISTORICAL COMPLAINT DATABASE SHOWS THIS IS THE SECOND REPORTED LEAK CONCERN FOR THIS PRODUCT CODE IN THE PREVIOUS ROLLING 12-MONTH PERIOD, NONE OF WHICH WERE ATTRIBUTED TO THE MANUFACTURING PROCESS CORRECTIVE ACTION: BASED ON THE COMPLAINT INVESTIGATION, THE CAUSE OF THIS ISSUE COULD NOT BE DETERMINED. THEREFORE, NO CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME. THIS FAILURE WILL BE MONITORED FOR FUTURE ACTIONS.

    Description of Event or Problem · 0

    TRIFURCATE SET LEAK FROM FILTER: APPEARS TO LEAK AT CONNECTION ON FILTER DISK.

    Description of Event or Problem · 0

    TRIFURCATE SET LEAK FROM FILTER- APPEARS TO LEAK AT CONNECTION ON FILTER DISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1295972 TRIFURCATED EXTENSION SET INTRAVASCULAR EXTENSION SET FPA VYGON USA AMS-944 2105026D

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO Male