BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH

    MDR report key: 18616170 · Received January 31, 2024

    Report

    Report Number
    2245270-2024-00010
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    December 28, 2023
    Report Date
    March 18, 2024
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K954302
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FAILED SAMPLE WILL BE RETURNED TO VYGON AND WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED WITH FDA WITHIN 30 DAYS OF COMPLETION.

    Additional Manufacturer Narrative · 0

    WE RECEIVED ONE CATHETER WITH A SEPARATED LL-HUB. IN THE DETACHED LL-HUB THE REMAINING EXTENSION LINE IS VISIBLE. MICROSCOPIC EXAMINATION OF THE LL-HUB REVEALED THAT THE REMAINING EXTENSION LINE HAS AN UNEVEN AND ROUGH SURFACE. THE FRACTURE PLANE OF THE SNAPPED EXTENSION LINE IS ALSO ROUGH AND UNEVEN. FURTHERMORE, THERE ARE LINES/GROOVES AT BOTH FRACTURE PLANES OF THE EXTENSION LINE. THIS INDICATES THAT THE EXTENSION LINE HAS BEEN SEVERED. THIS IS POSSIBLE IF THE CLAMP IS FIXED TOO OFTEN IN THE SAME PLACE, ESPECIALLY WHEN THE CLAMP IS FIXED JUST DISTAL TO THE LL-HUB. IN THIS AREA THE TENSILE FORCE HAS THE GREATEST EFFECT ON THE CATHETER AND THEREFORE CAN CAUSE SHEARING OF THE EXTENSION LINE. FURTHER EXAMINATION OF THE EXTENSION LINE SHOWS ADDITIONAL CONSTRICTIONS. THE SURFACE OF THESE CONSTRICTIONS SHOWED GROOVES AND CORRESPONDED TO THE POSITIONS WHERE THE SLIDING CLAMP WAS CLOSED. A REVIEW OF THE BATCH HISTORY RECORDS FOR 8173273 WAS PERFORMED, AND NO DEVIATIONS WERE FOUND. THE BATCH COMPLIED WITH ITS SPECIFICATIONS AND WAS RELEASED. EACH CATHETER IS FLOW AND LEAK-TESTED DURING PRODUCTION. THE TENSILE FORCE AND DIMENSIONS OF CATHETER COMPONENTS ARE RANDOMLY CHECKED DURING PRODUCTION. INCOMING GOODS INSPECTIONS AND TWO 100 % VISUAL TESTS AFTER PACKAGING ARE CONDUCTED WITH NO EXCEPTIONS FOUND. THERE HAS BEEN NO FURTHER COMPLAINT FOR BATCH 8173273 AND NO FURTHER COMPLAINT REGARDING A DETACHED LL-HUB ON CODE 4G07126120 WITHIN THE LAST THREE YEARS. THIS QUERY RELATES TO ALL THE COMPLAINTS THAT HAVE COME TO OUR ATTENTION WORLDWIDE. CORRECTIVE ACTION: AS THE CATHETER WORKED WELL FOR 34 DAYS BEFORE THE INCIDENT OCCURRED, WE DO NOT BELIEVE THIS DEFECT IS MANUFACTURING RELATED. DUE TO THIS, NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT DUE TO THIS COMPLAINT.

    Description of Event or Problem · 0

    WE HAD ONE OF OUR ONE FRENCH PICC LINES BREAK. IT BROKE CLOSE TO THE HUB THAT CONNECTS TO THE NEUTRAL PRESSURE VALVE AND TUBING FOR IV FLUIDS. IT LOOKS LIKE IT JUST SNAPPED.

    Description of Event or Problem · 0

    WE HAD ONE OF OUR ONE FRENCH PICC LINES BREAK. IT BROKE CLOSE TO THE HUB THAT CONNECTS TO THE NEUTRAL PRESSURE VALVE AND TUBING FOR IV FLUIDS. IT LOOKS LIKE IT JUST SNAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420416 PREMICATH LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1261.20G 22KO24D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown