BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 6169468 · Received December 13, 2016

    Report

    Report Number
    2245270-2016-00086
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    October 25, 2016
    Report Date
    April 24, 2017
    Manufacturer
    VYGON GMBH
    Product Code
    LJS
    PMA / PMN Number
    K052475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT AND RETURNED SAMPLE HAVE BEEN SUBMITTED TO VYGON (B)(4), WHICH IS WHERE THIS PART WAS MANUFACTURED, FOR EVALUATION. VYGON (B)(4) REPORTS THE FOLLOWING IN REGARD TO THIS COMPLAINT. EXAMINATION OF THE FAULTY SAMPLE SHOWED THAT THE CATHETER WAS LEAKING AT 32,4 CM. A TEAR/BURST WITH A LENGTH OF APPROXIMATELY 5 MM WAS VISIBLE WITH THE MICROSCOPE. THE CATHETER ALSO SHOWS A LOT OF OCCLUSION AT THE DISTAL PART. VYGON (B)(4) CONDUCTED EXTENSIVE LEAK TESTING NUTRILINE TWINFLOS FROM OUR STOCK, AND ALL PASS THE TEST PER ISO 10555 PART 1. THIS COMPLAINT IS NOT CONFIRMED TO BE A MANUFACTURING DEFECT, SINCE EACH CATHETER IS LEAK- AND FLOW-TESTED BEFORE PACKAGING, AND THE CATHETER PERFORMED WITHOUT LEAKS FOR 14 DAYS. CORRECTIVE ACTION: NO CORRECTIVE ACTION AT THIS TIME. HOWEVER, BOTH VYGON (B)(4) AND VYGON USA HAVE ENTERED THIS INCIDENT INTO OUR COMPLAINT LOGS AND WILL CONTINUE TO BE VIGILANT FOR THIS TYPE OF COMPLAINT.

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE MALFUNCTIONING DEVICE WAS NOT RETURNED TO VYGON FOR DEVICE EVALUATION THE DETAILS WILL BE EVALUATED AS PART OF THE COMPLAINT INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE STILL PENDING AND WILL BE COMMUNICATED TO FDA WITHIN THIRTY DAYS OF ITS CONCLUSION VIA FOLLOW-UP MDR.

    Description of Event or Problem · 1

    ON DAY 14 OF USE THE PICC WAS FOUND TO BE LEAKING. PATIENT OUTCOME: LINE REMOVED, NEW LINE INSERTED.

    Description of Event or Problem · 1

    ON DAY 14 OF USE THE PICC WAS FOUND TO BE LEAKING. PATIENT OUTCOME: LINE REMOVED, NEW LINE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821111 NUTRILINE LON TERM INTRAVASCUALR CATHETER LJS VYGON GMBH 1252.232M 16G001D

    Patients

    Seq Age Sex Outcome Treatment
    1