BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE TWINFLO 24G 30CM DUAL LUMEN CATHETER W/ STYLET, GRIP-LOK, & MICROFLASH

    MDR report key: 8723455 · Received June 21, 2019

    Report

    Report Number
    2245270-2019-00038
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    April 17, 2019
    Report Date
    August 12, 2019
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K052475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FAILED SAMPLE WAS RETURNED TO VYGON FOR DEVICE EVALUATION AS PART OF THE COMPLAINT INVESTIGATION. THE BONDING INSIDE THE Y-PIECE WAS GOOD AND AN IMPRINT OF THE STYLET INSIDE THE GLUE WAS VISIBLE. THIS CONFIRMS THAT THE JUNCTION OF THE STYLET AND THE Y-PIECE HAD A GOOD CONNECTION AT THE TIME OF MANUFACTURE. THE STYLET SHOWS A KINK AT 17.8 CM FROM THE PROXIMAL END. IF IS BELIEVED THAT THIS MAY HAVE BEEN CAUSED BY PULLING THE STYLET TOO HARD, WHICH CAUSED THE WIRE TO KINK. THE PRODUCT'S IFU SPECIFICALLY STATES, "IF DIFFICULTY IS EXPERIENCED REMOVING THE STYLET, LET THE VEIN REST FOR A MINUTE AND TRY REMOVAL AGAIN VERY SLOWLY. GENTLE FLUSHING OF THE CATHETER WITH SALINE MAY ASSIST IN STYLET REMOVAL." NO DEVIATIONS OF THE BATCH HISTORY RECORDS WERE DETECTED. EACH CATHETER IS FLOW AND LEAK TESTE, AND A 100% VISUAL TEST IS CARRIED OUT. THE TENSILE FORCE OF THE Y-PIECE AND STYLET IS RANDOMLY CHECKED. FOR THE INVOLVED BATCHES THE TENSILE FORCE WAS BETWEEN 5.52N AND 7.58N AND THEREFOR WITHIN THE SPECIFICATION. THIS IS THE 8TH COMPLAINT RECEIVED FOR BATCH 8023296. (B)(4). THERE ARE 9 OTHER COMPLAINTS FOR CODE 4G07125223 REGARDING STYLET REMOVAL ISSUES WITHIN THE PAST 3 YEARS, BUT NONE WERE DETERMINED TO BE MANUFACTURING RELATED. NO FURTHER CORRECTIVE ACTION WILL BE INITIATED AT THIS TIME BUY VYGON WILL CONTINUE TO MONITOR FOR THE ISSUE.

    Description of Event or Problem · 0

    THEY STYLET GOT STUCK AND WAS DIFFICULT TO REMOVE. IT BROKE AT THE HUB. THERE WAS NO APPARENT HARM TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE FAILED 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 COMMUNICATED TO FDA WITHIN 30 DAYS OF COMPLETION.

    Description of Event or Problem · 1

    THEY STYLET GOT STUCK AND WAS DIFFICULT TO REMOVE. IT BROKE AT THE HUB. THERE WAS NO APPARENT HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515806 NUTRILINE TWINFLO 24G 30CM DUAL LUMEN CATHETER W/ STYLET, GRIP-LOK, & MICROFLASH INTRAVASCULAR CATHETER, LONG TERM LJS VYGON GMBH 1252.230G 18A001D

    Patients

    Seq Age Sex Outcome Treatment
    1