BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH

    MDR report key: 18471863 · Received January 8, 2024

    Report

    Report Number
    2245270-2024-00001
    Event Type
    Malfunction
    Date Received
    January 8, 2024
    Date of Event
    December 9, 2023
    Report Date
    March 12, 2024
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K041468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WE RECEIVED ONE CATHETER AS A FAULTY SAMPLE FOR EVALUATION. THE CATHETER WAS OCCLUDED. DESPITE EFFORTS TO CLEAR THE CATHETER BY MASSAGING THE TUBE AND FLUSHING IT WITH WARM WATER, IT REMAINED BLOCKED AND IMPASSABLE. UNDER MICROSCOPIC EXAMINATION, A TEAR/HOLE WAS OBSERVED DIRECTLY BENEATH THE PINK ADAPTER, WHICH IS A TYPICAL SIGN OF A TENSILE FRACTURE DUE TO A HIGH TENSILE LOAD. THERE ARE VARIOUS POSSIBLE CAUSES THAT CAN LEAD TO CATHETER LEAKAGE/TENSILE FRACTURE: DRESSING CHANGE - IN SOME INSTANCES, THE CATHETER CAN BECOME ADHERED TO THE DRESSING AND ADDITIONAL PULLING IS REQUIRED TO FREE IT, PLACING STRESS ON THE LINE RESULTING IN A TENSILE FRACTURE. ROUTINE CARE - WHEN LIFTING THE BABY TO CHANGE BEDDING. MOVEMENT - THE BABY THEMSELVES CATCHING THE LINE, NORMALLY WITH A FOOT, DURING MOVEMENT. MECHANICAL DAMAGE BY A SHARP INSTRUMENT (FOR EXAMPLE SCISSORS, TOOTHED FORCEPS, OR SCALPEL) DURING DRESSING CHANGE. USE OF ALCOHOL-BASED DISINFECTANT. ACCORDING TO THE PRODUCT INCIDENT REPORT (PIR) FORM, THE CUSTOMER USED BOTH CHG AND ALCOHOL-BASED DISINFECTANTS. THERE IS A STATEMENT IN OUR PRODUCT'S IFU: "BE AWARE THAT ORGANIC SOLVENTS SUCH AS ALCOHOL OR ACETONE MAY INTERACT WITH CATHETER MATERIAL AND WEAKEN IT." AND "AVOID ANY CONTACT OF THE CATHETER TUBING TO ALCOHOL-CONTAINING DISINFECTANTS. THIS MAY IRREVERSIBLY DAMAGE THE CATHETER." A REVIEW OF THE BATCH HISTORY RECORDS WAS PERFORMED FOR 8138684 AND 8210782, AND NO DEVIATIONS WERE FOUND. THE BATCH COMPLIED WITH ITS SPECIFICATIONS AND WAS RELEASED. EACH CATHETER IS LEAK AND FLOW TESTED DURING PRODUCTION. THE TENSILE FORCE AND DIMENSIONS OF THE CATHETER/SET COMPONENTS ARE RANDOMLY CHECKED. INCOMING GOODS INSPECTIONS AND TWO 100% VISUAL TESTS AFTER PACKAGING ARE CARRIED OUT WITH NO EXCEPTIONS FOUND. THERE IS NO FURTHER COMPLAINT FOR BATCH 8210782, FOUR FURTHER COMPLAINTS FOR BATCH 8138684, AND NO FURTHER COMPLAINT REGARDING A LEAKING CATHETER ON CODE (B)(4) WITHIN THE LAST THREE YEARS. (B)(4). CORRECTIVE ACTION: NO FURTHER CORRECTIVE ACTION WAS INITIATED BY QUALITY MANAGEMENT DUE TO THIS COMPLAINT, AS THE CATHETER WORKED WELL FOR 2 DAYS BEFORE THE LEAKAGE OCCURRED, WE DO NOT BELIEVE THIS DEFECT IS MANUFACTURING-RELATED. ANY MANUFACTURING PROBLEMS THAT WOULD LEAD TO A LEAK WOULD BE DETECTED BY THE USER WHEN INITIALLY FLUSHING THE CATHETER. WHEN USING AN ALCOHOL-BASED DISINFECTANT, WE RECOMMEND FOLLOWING THE CATHETER HANDLING INSTRUCTIONS ACCORDING TO THE PRODUCT'S IFU.

    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.

    Description of Event or Problem · 0

    PICC LINE LEAKING AT PINK HUB 2 DAYS AFTER INSERTION. TROUBLESHOOTING AND LINE REMOVAL/REPLACEMENT WAS COMPLETED.

    Description of Event or Problem · 0

    PICC LINE LEAKING AT PINK HUB 2 DAYS AFTER INSERTION. TROUBLESHOOTING AND LINE REMOVAL/REPLACEMENT WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543989 PREMICATH LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1261.306A 23E014D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown