BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE TWINFLO NEONATAL PICC

    MDR report key: 4220538 · Received August 6, 2014

    Report

    Report Number
    2245270-2014-00060
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    June 10, 2014
    Report Date
    August 5, 2014
    Manufacturer
    VYGON GMBH.
    Product Code
    LJS
    PMA / PMN Number
    K052475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE TWO OCCURRENCES OF THIS COMPLAINT FROM THIS CUSTOMER. PLEASE REFERENCE THE FOLLOWING MDR FOR INFO CONCERNING THE ADDITIONAL OCCURRENCES: 2245270-2014-00061. ALTHOUGH THE MALFUNCTIONING SAMPLES WERE NOT RETURNED, THE COMPLAINT WAS SUBMITTED TO VYGON (B)(4) FOR A THOROUGH INVESTIGATION. VYGON WAS UNABLE TO CONFIRM THE COMPLAINT BECAUSE THE CATHETER WAS UNAVAILABLE FOR THEIR EXAMINATION. VYGON LEAK AND FLOW TESTS EVERY CATHETER BEFORE IT IS RELEASED FOR DISTRIBUTION. VYGON ALSO CHECKED THE BATCH HISTORY RECORD FOR THIS PRODUCT AND FOUND NO ABNORMALITIES. NO CORRECTIVE ACTION WILL BE IMPLEMENTED AT THIS TIME, BUT THIS INCIDENT WILL BE PLACED IN OUR COMPLAINT SYSTEM. WE WILL CONTINUE TO MONITOR FOR THIS TYPE OF PROBLEM.

    Description of Event or Problem · 1

    CATHETER WAS IN USE FOR SEVERAL DAYS BEFORE LEAKAGE WAS OBSERVED. THE LEAK WAS FOUND AFTER A 96 HOUR DRESSING CHANGE. THE DRESSING CHANGE CONSISTS OF SALINE SITE PREP AND TEGADERM DRESSING CHANGE. THE CUSTOMER DISCARDED BOTH SAMPLES, BUT REPORTED BELOW THE WINGS AFTER THE DRESSING CHANGE. NO PT INJURY WAS REPORTED AS A RESULT OF THE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459251 NUTRILINE TWINFLO NEONATAL PICC LONG TERM INTRAVASCULAR CATHETER LJS VYGON GMBH. 1252.232M 14D23

    Patients

    Seq Age Sex Outcome Treatment
    1