BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH

    MDR report key: 16232215 · Received January 24, 2023

    Report

    Report Number
    2245270-2023-00001
    Event Type
    Malfunction
    Date Received
    January 24, 2023
    Date of Event
    January 11, 2023
    Report Date
    March 17, 2023
    Manufacturer
    VYGON USA
    Product Code
    LJS
    PMA / PMN Number
    K041468
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SAMPLE IS STILL IN DECONTAMINATION PROCESS AND HAS NOT BEEN RETURNED FOR EVALUATION. THE RESULTS OF THIS INVESTIGATION IS STILL PENDING.

    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

    THE COMPLAINT WAS FORWARDED TO OUR PARENT COMPANY IN GERMANY FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: THE CUSTOMER RETURNED A 30 CM LONG PREMICATH WHICH RUPTURED AT 31 CM. MICROSCOPIC EXAMINATION SHOWED TYPICAL SIGNS OF TENSILE ELONGATION AND A ROUGH FRACTURE PLANE. FROM PREVIOUS COMPLAINTS WE LEARN OF VARIOUS POSSIBLE CAUSES OF A CATHETER LEAKAGE AND 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. WE DID NOT RECEIVE INFORMATION ABOUT THE DISINFECTANT USED FOR THIS CATHETER. 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." A REVIEW OF THE BATCH HISTORY RECORDS FOR 8091216 AND 8138684 WAS PERFORMED, AND NO DEVIATIONS WERE FOUND. THE BATCH COMPLIED TO ITS SPECIFICATIONS AND WERE RELEASED. EACH CATHETER IS LEAK AND FLOW TESTED DURING PRODUCTION. THE TENSILE FORCE OF THE CATHETER COMPONENTS IS RANDOMLY CHECKED. VISUAL TESTS AND INCOMING GOODS INSPECTIONS ARE CARRIED OUT WITH NO EXCEPTIONS FOUND. CORRECTIVE ACTION: AS THE CATHETER WORKED WELL FOR 6.5 DAYS BEFORE THE RUPTURE OCCURRED, WE DO NOT BELIEVE THIS DEFECT IS A MANUFACTURING RELATED. ANY MANUFACTURING PROBLEMS THAT WOULD LEAD TO A LEAK/RUPTURE WOULD BE DETECTED BY THE USER WHEN FLUSHING THE CATHETER. THEREFORE, NO FURTHER CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME.

    Description of Event or Problem · 0

    PREMICATH PICC LINE BROKE WHILE IN SITU. ENTIRE CATHETER WAS ABLE TO BE REMOVED. PICC LINE DISCONTINUED UPON REMOVAL AND PATIENT CONVERTED TO PERIPHERAL IV FOR REMAINDER OF IV THERAPY.

    Description of Event or Problem · 0

    PREMICATH PICC LINE BROKE WHILE IN SITU. ENTIRE CATHETER WAS ABLE TO BE REMOVED. PICC LINE DISCONTINUED UPON REMOVAL AND PATIENT CONVERTED TO PERIPHERAL IV FOR REMAINDER OF IV THERAPY.

    Description of Event or Problem · 0

    PREMICATH PICC LINE BROKE WHILE IN SITU. ENTIRE CATHETER WAS ABLE TO BE REMOVED. PICC LINE DISCONTINUED UPON REMOVAL AND PATIENT CONVERTED TO PERIPHERAL IV FOR REMAINDER OF IV THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619273 PREMICATH LONG-TERM INTRAVASCULAR CATHETER LJS VYGON USA 1261.306A 22H004D

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown