BEUDAMED
    FDA Adverse Event Other Summary report: N

    XCELA POWER INJECTABLE PORT

    MDR report key: 3122636 · Received May 16, 2013

    Report

    Report Number
    2032582-2013-00001
    Event Type
    Other
    Date Received
    May 16, 2013
    Date of Event
    March 6, 2013
    Report Date
    May 16, 2013
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR INVESTIGATION. UNABLE TO ASCERTAIN THE CAUSE OF THE REPORTED PROBLEM. DEVICE HISTORY RECORD WAS REVIEWED. ALL QUALITY RECORDS ARE COMPLETE AND IN ORDER. NO NON-CONFORMITY AND NO SIMILAR COMPLAINT WERE RECORDED FOR THIS LOT NUMBER. DEVICES ARE 100% LEAK TESTED. RISK OF PORT LEAKAGE IS IDENTIFIED IN THIS RISK ANALYSIS. REVIEW OF LABELING SHOWS DETAILED/ADEQUATE INSTRUCTION TO SAFELY ACCESS THE PORT WITH A NON-CORING NEEDLE. MOST FREQUENT CAUSE OF A PORT LEAKAGE IS AN IMPROPERLY ACCESSING THE PORT.

    Description of Event or Problem · 1

    AS REPORTED IN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216603 XCELA POWER INJECTABLE PORT IMPLANTED PORT AND CATHETER SYSTEM LJT PFM MEDICAL, INC 121332 000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other