BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENCAN SPINAL TRAYS

    MDR report key: 3210062 · Received June 27, 2013

    Report

    Report Number
    2523676-2013-00191
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    April 16, 2013
    Report Date
    June 3, 2013
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K932569
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVAL. WITHOUT THE ACTUAL SAMPLE OR LOT NUMBER, A THOROUGH EVAL COULD NOT BE PERFORMED AND NO SPECIFIC CONCLUSIONS CAN BE DRAWN. HOWEVER, INCIDENTS OF THIS NATURE HAVE GENERALLY BEEN ATTRIBUTED TO THE NEEDLE BEING SUBJECTED TO SOME TYPE OF TRAUMA DURING USE THAT STRESSES THE DEVICE BEYOND ITS DESIGN CAPABILITIES. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE PRODUCT CATALOG NUMBER IDENTIFIED IN THE REPORTED EVENT. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE DEVICE MFR OF THE NEEDLE. IF ADD'L PERTINENT INFO BECOMES AVAILABLE, A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY THROUGH MEDWATCH # (B)(4): PT SCHEDULED FOR CESAREAN SECTION. SPINAL PLACED BY PHYSICIAN, NEEDLE BROKE DURING PLACEMENT. SURGICAL PROCEDURE NEEDED TO REMOVE BROKEN NEEDLE. DURING A F/U CALL TO THE FACILITY, THE REPORTER INDICATED THAT THE BROKEN PIECE OF THE NEEDLE WAS SUCCESSFULLY REMOVED FROM THE PT AND THAT THE PT DID NOT NEED ANY ADD'L MEDICAL INTERVENTION AFTER THE REMOVAL OF THE PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293355 PENCAN SPINAL TRAYS P27BK PENCAN SPINAL W/BUPIVAC CAZ B. BRAUN MEDICAL, INC. P27BK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other| R