BEUDAMED
    FDA Adverse Event Other Summary report: N

    UP NANOLINE LONG 50 GAUGE 25

    MDR report key: 1994413 · Received February 2, 2011

    Report

    Report Number
    9611612-2011-00035
    Event Type
    Other
    Date Received
    February 2, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 2, 2011
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K053283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS POINT, NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD AND RELEVANT RAW MATERIAL HISTORY FILES OF THE REPORTED BATCH DID NOT INDICATE RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. ANY FURTHER INFO WILL BE SENT IN TO FDA AS SOON AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    (B)(4). EVENT TOOK PLACE IN (B)(6), HAS NOT BEEN REPORTED TO (B)(4)AUTHORITY. TENTATIVE SUMMARIZING TRANSLATION OF USER'S NARRATIVE: LEAK OF THE NEEDLE. NOTICED PRIOR TO USE, DEVICE WAS REPLACED. NINETEEN SUSPICIOUS PCS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UP NANOLINE LONG 50 GAUGE 25 868.5150 ANESTHESIA CONDUCTION NEEDLE CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 001156-81 886

    Patients

    Seq Age Sex Outcome Treatment
    1 Other