BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPISPIN LOCK

    MDR report key: 1740719 · Received June 17, 2010

    Report

    Report Number
    9611612-2010-00011
    Event Type
    Other
    Date Received
    June 17, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 17, 2010
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K060563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PHOTOGRAPHS OF THE DEVICE HAVE BEEN SENT TO MANUFACTURER FOR EVALUATION. NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD AND THE RAW MATERIAL HISTORY FILES FOR THE REPORTED BATCH SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. THE ADAPTER WAS MOUNTED INCORRECTLY. AS A RESULT OF THE EVALUATION THIS IS PROVEN TO BE A SINGLE DEVICE ERROR DUE TO HUMAN FAILURE IN MANUFACTURING. PAJUNK CONSIDERS THIS FILE AS CLOSED.

    Description of Event or Problem · 1

    (B)(4). EVENT TOOK PLACE IN (B)(6). PRIOR TO USE OF EPISPIN LOCK SYSTEM FOR COMBINED SPINAL-EPIDURAL REGIONAL ANESTHESIA USER BECAME AWARE OF LOCKING ADAPTER (CLAMPING MECHANISM) NOT WORKING PROPERLY. HAD TO USE ANOTHER IT. PATIENT WAS NOT AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPISPIN LOCK CAZ 868.5140 ANESTHESIA CONDUCTION KIT CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 0021351-30 847

    Patients

    Seq Age Sex Outcome Treatment
    1 Other