BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLEXOLONG SPEZIAL SET ACC. MEIER

    MDR report key: 2667109 · Received December 23, 2005

    Report

    Report Number
    9611612-2005-00002
    Event Type
    Other
    Date Received
    December 23, 2005
    Date of Event
    December 12, 2005
    Report Date
    December 1, 2005
    Manufacturer
    PAJUNK GMBH
    Product Code
    BSP
    Removal / Correction Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT TOOK PLACE AT (B)(6). IT IS NOT CLEAR WHETHER IT IS A PAJUNK DEVICE OR NOT. PHYSICIAN PROMISED TO SEND DEVICE FOR EVALUATION.

    Description of Event or Problem · 1

    DURING REGIONAL ANESTHESIA OPERATING ROOM WITH CANNULA AND CATHETER IN POSITION THE PT MADE TWO VEHEMENT MOVES WITH HIS ARM. BECAUSE OF THESE MOVEMENTS THE CATHETER WAS PUSHED AGAINST THE SHARP CANNULA AND FINALLY CUT OFF. THREE CENTIMETERS OF THE CATHETER ARE STILL MISSING AND ACCORDING TO THE X-RAY SUPPOSED TO BE STILL IN THE PT'S BODY. IN A SECOND OPERATING ROOM PHYSICIAN TRIED TO REMOVE THE CATHETER, BUT WAS NOT SUCCESSFUL. THREE CENTIMETERS OF CATHETER ARE SUPPOSED TO BE STILL IN THE PT. THE DEVICE WILL BE SENT TO MANUFACTURER FOR EVALUATION. HAS NOT ARRIVED YET, SO IT IS NOT CLEAR, THAT IT IS A PAJUNK DEVICE. IDENTIFICATION AND BRAND INFORMATION ARE NAMED BY REPORTING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLEXOLONG SPEZIAL SET ACC. MEIER PLEXOLONG SET BSP BSP PAJUNK GMBH 531151-31A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention