BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUTRILINE

    MDR report key: 6169460 · Received December 13, 2016

    Report

    Report Number
    2245270-2016-00085
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 11, 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 REGARDS TO THIS COMPLAINT. EXAMINATION OF THE FAULTY SAMPLE SHOWED THAT THE CATHETER WAS LEAKING AT THE JUNCTION BETWEEN CATHETER AND WING. A MICROSCOPIC EXAMINATION SHOWED A RADIAL TEAR/BREAKAGE AT THAT POINT. IT IS UNUSUAL THAT A CATHETER SHOWS SUCH A DAMAGE IMMEDIATELY AFTER INSERTION. ONCE POSSIBLE CAUSE OF A RADIAL TEAR IS EXCESS BENDING AND TWISTING AT THAT JOINT. THIS COMPLAINT IS NOT CONFIRMED TO BE A MANUFACTURING DEFECT, SINCE EACH CATHETER IS LEAK- AND FLOW-TESTED BEFORE PACKAGING. CORRECTIVE ACTION: NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME; HOWEVER, BOTH VYGON GERMANY 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

    THE MALFUNCTIONING DEVICE HAS BEEN RETURNED TO VYGON FOR DEVICE EVALUATION 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

    SMALL PIN HOLE LEAK ON ORANGE SIDE NEAR HUB. LINE WAS JUST INSERTED WHEN LEAK WAS FOUND. NO DRESSING OR STERI STRIP WAS EVER APPLIED. PATIENT OUTCOME: LINE REMOVED, NEW LINE INSERTED.

    Description of Event or Problem · 1

    SMALL PIN HOLE LEAK ON ORANGE SIDE NEAR HUB. LINE WAS JUST INSERTED WHEN LEAK WAS FOUND. NO DRESSING OR STERI STRIP WAS EVER APPLIED. PATIENT OUTCOME: LINE REMOVED, NEW LINE INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821402 NUTRILINE LON TERM INTRAVASCUALR CATHETER LJS VYGON GMBH 1252.232M 16G001D

    Patients

    Seq Age Sex Outcome Treatment
    1