BEUDAMED
    FDA Adverse Event Other Summary report: N

    SONOLONG ECHO

    MDR report key: 3772388 · Received February 27, 2014

    Report

    Report Number
    9611612-2014-00002
    Event Type
    Other
    Date Received
    February 27, 2014
    Date of Event
    January 20, 2014
    Report Date
    February 27, 2014
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    CAZ
    PMA / PMN Number
    K062900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION 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

    (B)(4). CATHETER BROKE APART UPON REMOVAL, REQUIRED INTERVENTION TO RETRIEVE FRAGMENT FROM PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122639 SONOLONG ECHO 868.5120 ANESTHESIA CONDUCTION CATHETER CAZ PAJUNK GMBH MEDIZINTECHNOLOGIE 531185-31CU 998

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention