BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEGUARD HUBER NEEDLE SET

    MDR report key: 3123893 · Received May 15, 2013

    Report

    Report Number
    2245270-2013-00020
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 15, 2013
    Manufacturer
    VYGON MANUFACTURING
    Product Code
    FPA
    PMA / PMN Number
    K013871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS AN ADDITIONAL OCCURRENCES OF THIS PRODUCT MALFUNCTION. PLEASE REFERENCE THE FOLLOWING FOR THE ADDITIONAL OCCURRENCE: MDR 2245270-2013-00021. ALTHOUGH THE FAILED SAMPLE WAS NOT RETURNED TO VYGON U.S., THE COMPLAINT HAS BEEN FORWARDED TO VYGON MANUFACTURING FOR EVAL AND INVESTIGATION. THE RESULTS OF THIS INVESTIGATION WILL BE FORWARDED IN A FOLLOW-UP MDR WITHIN 30 OF ITS CONCLUSION.

    Description of Event or Problem · 1

    A SALINE SYRINGE WAS ATTACHED TO A HUBER NEEDLE SET TO CLEAR AN IMPLANTABLE PORT. WHEN THE NURSE MADE ACCESS TO THE PORT SHE BEGAN TO INJECT THE SALINE SHE FOUND THE SALINE LEAKING FROM THE SET WHERE THE TUBING IS BONDED TO THE NEEDLE ASSEMBLY. THE PT DID NOT EXPERIENCE ANY NEGATIVE OUTCOME FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214593 LIFEGUARD HUBER NEEDLE SET HUBER NEEDLE SET FPA VYGON MANUFACTURING CLG-2010 1301036

    Patients

    Seq Age Sex Outcome Treatment
    1