BEUDAMED
    FDA Adverse Event Other Summary report: N

    EPILONG

    MDR report key: 3772377 · Received February 27, 2014

    Report

    Report Number
    9611612-2014-00003
    Event Type
    Other
    Date Received
    February 27, 2014
    Date of Event
    February 5, 2014
    Report Date
    February 27, 2014
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K060311
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTIVE OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE RELEVANT DEVICE HISTORY RECORDS AND THE RAW MATERIAL HISTORY FILES DID NEITHER INDICATE RECORDED QUALITY PROBLEMS NOR REJECTIONS RELATED TO THIS INCIDENT. IF ANY FURTHER INFO IS BECOMING AVAILABLE, MFR IMMEDIATELY WILL INFORM FDA. IF NO FURTHER INFO IS BECOMING AVAILABLE, MFR CONSIDERS THIS FILE AS CLOSED.

    Description of Event or Problem · 1

    INTERNAL REPORT NUMBER: (B)(4). EVENT TOOK PLACE IN THE (B)(6) AND HAS BEEN REPORTED TO (B)(6). AS EPIDURAL FOR LABOUR WAS INSERTED WITH EASE. FOLLOWING THIS, AN ATTEMPT TO ADMINISTER THE USUAL TEST DOSE WAS MADE, HOWEVER, EXTREME RESISTANCE TO INJECTION WAS ENCOUNTERED. THE EPIDURAL WAS REMOVED, AND WAS FOUND TO HAVE KINKED AT THE 5 CM MARK. THIS NECESSITATED THE INSERTION OF ANOTHER EPIDURAL. REPORTED AS ANOTHER BATCH HAS ALREADY BEEN WITHDRAWN BY THE MFR AND ALLEGEDLY NEW CATHETER DESIGN TO BE RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123030 EPILONG 868.5120 ANESTHESIA CONDUCTION CATHETER CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 0331155-49 1041

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention