BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMICATH

    MDR report key: 22365444 · Received June 30, 2025

    Report

    Report Number
    2245270-2025-00060
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 7, 2025
    Report Date
    September 2, 2025
    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

    THE MALFUNCTIONING DEVICE WILL BE RETURNED FOR EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. UPON RECEIPT, IT WILL BE INVESTIGATED. THE RESULTS OF THIS INVESTIGATION ARE STILL PENDING AND WILL BE REPORTED TO THE FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA A FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT WAS FORWARDED TO OUR PARENT COMPANY IN GERMANY FOR THEIR EVALUATION. THE INVESTIGATION SUMMARY IS AS FOLLOWS: WE RECEIVED THE CATHETER AS A FAULTY SAMPLE, CONNECTED TO A NEEDLE-FREE CONNECTOR (NOT A VYGON GERMANY GMBH PRODUCT) AND WITHOUT THE SLIDING CLAMP. A KNOT WAS VISIBLE INSIDE THE CATHETER TUBE AT THE 20 CM MARKING, AND THE TUBE HAD SNAPPED DIRECTLY AT THE PINK ADAPTER. MICROSCOPIC EXAMINATION REVEALED DRIED SOLUTION RESIDUES. BOTH FRACTURE SURFACES APPEARED ROUGH AND UNEVEN, INDICATING THE APPLICATION OF EXCESSIVE TENSILE FORCE AND POTENTIAL DAMAGE CAUSED BY ALCOHOL-BASED DISINFECTION. IN GENERAL, THERE ARE VARIOUS EVENTS THAT CAN LEAD TO A SNAPPED CATHETER: 1. TENSILE FORCE WHICH MAY BE CAUSED BY: - 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 COULD RESULT IN A TENSILE FRACTURE - FOR BABIES, ROUTINE CARE (WHEN LIFTING THE BABY TO CHANGE THE BEDDING) AND MOVEMENT OF THE BABY ITSELF COULD RESULT IN A TENSILE FRACTURE. 2. MECHANICAL DAMAGE BY A SHARP INSTRUMENT (FOR EXAMPLE SCISSOR, FORCEPS OR SCALPEL) DURING DRESSING CHANGE. 3. ALCOHOL-BASED DISINFECTANT - CONCERNING THIS, THERE IS A WARNING IN THE IFU: "BE AWARE THAT ORGANIC SOLVENTS SUCH AS ALCOHOL OR ACETONE MAY INTERACT WITH CATHETER MATERIAL AND WEAKEN IT." IN ADDITION, A MANUFACTURING FAULT CAN BE EXCLUDED AS EACH CATHETER IS FLOW AND LEAK-TESTED DURING PRODUCTION, AND THE CATHETER DID NOT LEAK FOR 9 DAYS AS STATED BY THE CUSTOMER. FURTHERMORE, THE IFU STATES: - CAUTION: DO NOT STRETCH THE CATHETER OR SUBJECT IT TO PRESSURE ABOVE 21,75 PSI (1,5 BAR, 1125 MMHG). DO NOT USE SMALL SYRINGES AS THESE CAN GENERATE VERY HIGH PRESSURES. IT IS POSSIBLE TO GENERATE 4 OR 5 TIMES THE MAXIMUM SAFETY PRESSURE, WITH ANY SIZE OF HAND-HELD SYRINGE. SUBJECTING THE CATHETER TO PRESSURE ABOVE 21,75 PSI CAN RESULT IN CATHETER RUPTURE AND EMBOLISM. SMALLER SYRINGES GENERATE HIGHER PRESSURES THAN LARGER ONES. - DO NOT BEND THE CATHETER OR THE EXTENSION LINE PERMANENTLY TO AVOID DAMAGE TO THE CATHETER. - DO NOT OVERSTRETCH THE CATHETER AS IT MAY RUPTURE, AND REBOUND INTO THE INSERTION SITE, CAUSING A CATHETER EMBOLISM. A REVIEW OF THE COMPONENT BATCH HISTORY RECORDS WAS PERFORMED, AND NO DEVIATIONS WERE FOUND. THE BATCHES COMPLIED WITH THEIR SPECIFICATIONS AND WERE RELEASED. EACH CATHETER IS FLOW AND LEAK TESTED DURING PRODUCTION. THE TENSILE FORCE AND DIMENSIONS OF CATHETER AND SET COMPONENTS ARE RANDOMLY CHECKED. INCOMING GOODS INSPECTIONS AND TWO 100% VISUAL INSPECTIONS AFTER PACKAGING ARE CONDUCTED DURING THE MANUFACTURING PROCESS. A 2-YEAR REVIEW OF VYGON USA'S COMPLAINT DATA SHOWS THIS IS THE ONLY COMPLAINT REPORTED FOR LOT 25D019D RELATED TO LEAKING CATHETERS. CORRECTIVE ACTION: AS THE CATHETER FUNCTIONED AS INTENDED FOR 9 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. AS A RESULT, NO FURTHER CORRECTIVE ACTION HAS BEEN INITIATED BY VYGON GERMANY GMBH QUALITY MANAGEMENT AT THIS TIME.

    Description of Event or Problem · 0

    VYGON PICC CATHETER (LOT #25D019D) INSERTED ON (B)(6). IT WAS NOTED ON (B)(6) THAT IT WAS LEAKING AT THE PICC SITE DURING THE LAST DOSE OF ANTIBIOTICS WAS RUNNING. THE DRESSING WAS REMOVED PER PP AND IT WAS NOTED THAT THE CATHETER WAS BROKE OFF RIGHT AT THE PINK HUB, CATHETER WAS REMOVED PER PP BUT MET WITH SOME RESISTANCE AT THE 10CM MARK, THE CATHETER WAS SUCCESSFULLY REMOVED, WITH BLACK TIP INTACT. XRAYS WERE DONE TO CONFIRM THERE WERE NO REMNANTS OF THE CATHETER THAT MAY HAVE ACCIDENTALLY BROKEN OFF DURING THE REMOVAL.

    Description of Event or Problem · 0

    VYGON PICC CATHETER (LOT #25D019D) INSERTED ON (B)(6). IT WAS NOTED ON JUNE7 THAT IT WAS LEAKING AT THE PICC SITE DURING THE LAST DOSE OF ANTIBIOTICS WAS RUNNING. THE DRESSING WAS REMOVED PER PP AND IT WAS NOTED THAT THE CATHETER WAS BROKE OFF RIGHT AT THE PINK HUB, CATHETER WAS REMOVED PER PP BUT MET WITH SOME RESISTANCE AT THE 10CM MARK, THE CATHETER WAS SUCCESSFULLY REMOVED, WITH BLACK TIP INTACT. XRAYS WERE DONE TO CONFIRM THERE WERE NO REMNANTS OF THE CATHETER THAT MAY HAVE ACCIDENTALLY BROKEN OFF DURING THE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2291479 PREMICATH INTRAVASCULAR CATHETER LJS VYGON USA 1261.306A 25D019D

    Patients

    Seq Age Sex Outcome Treatment
    1 19 DA Unknown