BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNK

    MDR report key: 974862 · Received March 16, 2007

    Report

    Report Number
    9611612-2007-00002
    Event Type
    Other
    Date Received
    March 16, 2007
    Date of Event
    January 7, 2007
    Report Date
    March 15, 2007
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    MIA
    PMA / PMN Number
    K911202
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    PAJUNK AS MFR HAS BEEN INFORMED BY FDA ABOUT INCIDENT AND INCIDENT REPORT. FURTHER INQUIRIES ALLOWED DO GATHER DETAILED INFO, BUT PAJUNK IS STILL NOT ABLE TO DETERMINE IF THIS IS A PRODUCT MANUFACTURED BY PAJUNK. NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE POSSIBLY AFFECTED DEVICE HISTORY RECORD, STERILIZATION RECORD (BATCH 630) AND THE RAW MATERIAL HISTORY FILES FOR THE REPORTED BATCH SHOWED NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT. THE INCIDENT WAS NOT REPORTED TO PAJUNK INITIALLY BY USER FACILITY. IMPLICITLY SUPPOSED THIS IS A PAJUNK DEVICE, THE DESCRIPTION OF THE INCIDENT INDICATES IT IS A USER ERROR ANYHOW. IN THE USER MANUAL FOR SPINAL NEEDLES A SPECIAL WARNING REGARDING BONE CONTACT AND INSERTION FORCE USED TO ADVANCE CANNULA IS CLEARLY GIVEN. PT IS DOING WELL. IF NO FURTHER INFO IS AVAILABLE ALLOWING PAJUNK TO DETERMINE IF IT IS A PAJUNK PRODUCT THE FILE IS CONSIDERED AS CLOSED.

    Description of Event or Problem · 1

    WHILE ATTEMPTING SAB, BONE ENCOUNTERED AFTER APPLYING PRESSURE TO NEEDLE WHILE ADVANCING. NEEDLE BEING REMOVED TO REDIRECT, USER NOTED A PART OF THE NEEDLE MISSING AND BROKE. USER COULD PALPATE THE BROKEN NEEDLE JUST UNDER SKIN. PHYSICIAN MADE A 6CM INCISION MID BACK L4-5. AT 3CM DEEP THE NEEDLE WAS GRASPED BY FORCEP AND REMOVED INTACT. NO FRAGMENTS REMAIN WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK SPINAL NEEDLE, 22G X 4,75 INCH MIA PAJUNK GMBH MEDIZINTECHNOLOGIE UNK 630

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention