BEUDAMED
    FDA Adverse Event Other Summary report: N

    RECTUS SHEATH TAP-KIT

    MDR report key: 3020623 · Received March 18, 2013

    Report

    Report Number
    9611612-2013-00002
    Event Type
    Other
    Date Received
    March 18, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 18, 2013
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSO
    PMA / PMN Number
    K113207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 DID NOT INDICATE RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. ANY FURTHER INFO WILL BE SENT TO THE 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) AND HAS BEEN REPORTED TO THE (B)(6). FROM USER'S/INITIAL REPORTER'S NARRATIVE: "WHILE ATTEMPTING TO PLACE A TAP CATHETER (LOCAL ANAESTHETIC INFUSION CATHETER IN THE MUSCULATURE OF THE ABDOMINAL WALL), THE OPERATOR (WHO I WAS SUPERVISING) COULD NOT SEEM TO PASS THE CATHETER OUT THROUGH THE TUOHY NEEDLE SUPPLIED WITH THE KIT. THE CATHETER WAS WITHDRAWN, AS IT WAS BELIEVED THAT THE CATHETER HAD NOT EXITED THE TIP OF THE NEEDLE. THE TIP HAD, HOWEVER, AND THE DIGITAL 3 CM OF THE CATHETER SHEARED OFF AND WAS RETAINED IN THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112996 RECTUS SHEATH TAP-KIT 868.5150 ANESTHESIA CONDUCTION NEEDLE BSO PAJUNK GMBH MEDIZINTECHNOLOGIE 0721153-49 993

    Patients

    Seq Age Sex Outcome Treatment
    1 Other