BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFINE PENTIPS

    MDR report key: 2507872 · Received November 29, 2011

    Report

    Report Number
    9612764-2011-00002
    Event Type
    Injury
    Date Received
    November 29, 2011
    Date of Event
    February 26, 2010
    Report Date
    November 25, 2011
    Manufacturer
    OWEN MUMFORD LTD
    Product Code
    FMI
    PMA / PMN Number
    K973899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ARTSANA HAS PERFORMED A RETROSPECTIVE REVIEW OF ADVERSE EVENT REPORTED ON MAUDE SYSTEM. AT THE END OF REVIEW, ARTSANA DECIDE TO SUBMIT TO FDA THE 3500A FORM. ISSUE: INJURY NEEDLE BREAK-OFF. WE HAVE RECEIVED THE DEFECTIVE SAMPLE FROM OWEN MUMFORD AND WE HAVE PERFORMED ON THAT THE FOLLOWING TEST/INVESTIGATION: 50X VISUAL EXAMINATION BY STEREOMICROSCOPE. REVIEW THE DEVICE HISTORY RECORD. TOOK 20 RESERVE SAMPLES AND ANALYZED BY STEREOMICROSCOPE X50 ENLARGEMENTS. THESE TESTS WERE PERFORMED ON (B)(6) 2010 WITHOUT DETACHING ANY ISSUES. INTO THE SHIELD OF THE RETURNED SAMPLE WE FOUND SEVERAL SCRATCHES THAT COULD MEAN THAT THE SHIELD HAS BEEN REINSERTED MORE TIMES SO THE DEVICE COULD HAS BEEN REUSED MORE THAN ONE TIME. THE INVESTIGATION REPORTED THAT THE NEEDLE FRACTURE WAS DUCTILE AND WAS DUE TO APPLIED OVERLOAD FORCE. ALL ARTSANA PEN NEEDLE ARE CONFORMED TO THE ISO 9626 "STAINLESS STEEL NEEDLE TUBING FOR MFR OF MEDICAL DEVICES" WITH NORMAL SINGLE WAS BENDING / BREAKING SHOULD NOT OCCUR". NO FURTHER ACTION. NO OTHER RELATED COMPLAINTS WERE RAISED AGAINST THIS LOT.

    Description of Event or Problem · 1

    OWEN MUMFORD (LEGAL MFR) HAD NOTIFIED TO ARTSANA GROUP SPA (ACTUAL MFR) ON (B)(6) 2010 THAT THE PT USING A UNIFINE PENTIPS HAD BEEN HOSPITALIZED IN ORDER TO CARRY OUT SURGERY TO REMOVE A PIECE OF NEEDLE THAT HAD BROKEN OFF IN THE PT'S SKIN. REPORTER'S DIALOG: "THE CANNULA WAS BROKEN AND STAYED UNDER THE SKIN. THE PT WAS HOSPITALIZED FOR TWO DAYS FOR SURGERY TO REMOVE THE CANNULA FROM UNDER THE SKIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIFINE PENTIPS UNIFINE FMI OWEN MUMFORD LTD AN3590 0804742

    Patients

    Seq Age Sex Outcome Treatment
    1 Other