BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENCAN PENCIL POINT SPINAL NEEDLE

    MDR report key: 1083574 · Received July 16, 2008

    Report

    Report Number
    2523676-2008-00064
    Event Type
    Other
    Date Received
    July 16, 2008
    Date of Event
    April 29, 2008
    Report Date
    June 23, 2008
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    MIA
    PMA / PMN Number
    K932569
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE IN THE INCIDENT WAS DISCARDED AND WAS NOT MADE AVAILABLE FOR EVAL, AND A LOT NUMBER WAS NOT REPORTED. WITHOUT THE ACTUAL SAMPLE AND A LOT NUMBER, A COMPLETE EVAL COULD NOT BE PERFORMED. INCIDENTS OF THIS NATURE ARE GENERALLY DUE TO THE CANNULA ENCOUNTERING SOME TYPE OF TRAUMA WHICH STRESSES THE PART BEYOND ITS INTENDED DESIGN CAPABILITIES. WITHOUT THE ACTUAL SAMPLE TO EVALUATE NO SPECIFIC CONCLUSIONS CAN BE DRAWN. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE MFR B. BRAUN.

    Description of Event or Problem · 1

    AS REPORTED ON THE MEDWATCH FORM: "PT BROUGHT TO OR FOR C-SECTION WAS POSITIONED FOR SPINAL ANESTHESIA. PT REMAINED STILL AND IN POSITION - SITTING ON EDGE OF OR TABLE - DURING PLACEMENT OF SPINAL WITH MINIMAL MANIPULATION OF NEEDLE WHEN DOCTOR REMOVED SPINAL NEEDLE TO REATTEMPT INSERTION OF 3CM PORTION OF NEEDLE MISSING. PT WILL BE COMING IN TO REMOVE NEEDLE." MEDWATCH # MW5006644. ADD'L INFO PROVIDED BY THE FACILITY INDICATED THE FRAGMENTED PIECE OF NEEDLE WAS SURGICALLY REMOVED WITHOUT INCIDENT. THE PT SUFFERED NO ADD'L ADVERSE SEQUELA ASSOCIATED WITH THE REPORTED INCIDENT. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVAL AND THE LOT NUMBER REMAINS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENCAN PENCIL POINT SPINAL NEEDLE PENCAN SPINAL NEEDLE MIA B. BRAUN MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other