BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLEXOLONG KIT

    MDR report key: 2507406 · Received February 10, 2012

    Report

    Report Number
    9611612-2012-00002
    Event Type
    Other
    Date Received
    February 10, 2012
    Date of Event
    January 27, 2012
    Report Date
    February 9, 2012
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K042979
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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. PRIOR TO SHIPMENT/RELEASE THE DEVICE IS TESTED 100%. 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

    EVENT TOOK PLACE IN (B)(6) AND HAS NOT BEEN REPORTED TO (B)(6) AUTHORITIES. TENTATIVE TRANSLATION OF USER'S NARRATIVE: "UPON REMOVAL OF THE STYLET FROM CATHETER POSITIONED FEMORAL THE STYLET GOT STUCK. EVEN THOUGH REMOVED CAREFULLY THE CATHETER AS WELL AS THE STYLET BROKE/WERE TORN APART. UNABLE TO REMOVE FRAGMENTS (CATHETER AND STYLET) FROM PT. FRAGMENTS REMAIN WITH PT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXOLONG KIT KIT, ANAESTHESIA CONDUCTION CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 931

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention