BEUDAMED
    FDA Adverse Event Other Summary report: N

    SPROTTE

    MDR report key: 2253150 · Received August 23, 2011

    Report

    Report Number
    9611612-2011-00056
    Event Type
    Other
    Date Received
    August 23, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 5, 2011
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    PMA / PMN Number
    K911260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. IF NO FURTHER INFO BECOMES AVAILABLE PAJUNK CONSIDERS THIS FILE AS CLOSED.

    Description of Event or Problem · 1

    (B)(4). EVENT TOOK PLACE IN (B)(6). USERS NARRATIVE: PT HAVING LUMBER PUNCTURE ON WARD AND WHEN NEEDLE WAS BEING REMOVED IT SNAPPED LEAVING PART OF NEEDLE IN PT. THE DISTAL PORTION OF THE NEEDLE BROKE OFF IN THE PT. PT HAD SURGICAL PROCEDURE TO REMOVE REMAINDER OF NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPROTTE 868.5150 ANESTHESIA CONDUCTION NEEDLE. BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 121151-30A 903

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention