BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORT-A-CATH GRIPPER NEEDLE

    MDR report key: 1942786 · Received December 20, 2010

    Report

    Report Number
    2183502-2010-00613
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    November 22, 2010
    Report Date
    December 18, 2010
    Manufacturer
    SMITHS MEDICAL MD (FORMERLY DELTEC, INC)
    Product Code
    FPA
    PMA / PMN Number
    K870866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MANUFACTURER FOR DEVICE EVALUATION. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MANUFACTURER WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    A REPORT WAS REC'D THAT STATED THE PT WAS RECEIVING AN INFUSION VIA AN IMPLANTABLE PORTAL ACCESS SYSTEM. THE SUSPECT MEDICAL DEVICE WAS UTILIZED AS THE NEEDLE AND THE CANNULA OF THE NEEDLE WAS INSERTED INTO THE PORTAL OF THE ACCESS SYSTEM. REPORTEDLY WHEN THE STAFF REMOVED THE DRESSING FROM AROUND THE NEEDLE, THE CANNULA HAD BROKEN OFF AND REMAINED LODGED WITHIN THE PORTAL OF THE IMPLANTED ACCESS SYSTEM. THE NEEDLE WAS REMOVED WITHOUT SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT-A-CATH GRIPPER NEEDLE FPA- SET, ADMINISTRATION, INTRAVASCULAR FPA SMITHS MEDICAL MD (FORMERLY DELTEC, INC) 21-2733 182X39

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PORT-A-CATH