BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPROTTE

    MDR report key: 3987649 · Received July 23, 2014

    Report

    Report Number
    9611612-2014-00014
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 23, 2014
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    BSP
    PMA / PMN Number
    K911260
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO SPECIFIC CORRECTIVE ACTION DUE TO MITIGATIVE PREVENTION OF HAZARDS IS ASSIGNED TO THIS REPORT. A REVIEW OF THE RELEVANT RECORDS AND THE RAW MATERIAL FILES OF THE AFFECTED BATCH DID NEITHER INDICATE RECORDED QUALITY PROBLEMS NOR REJECTIONS RELATED TO THIS INCIDENT. IF ANY FURTHER INFORMATION IS BECOMING AVAILABLE, MFR IMMEDIATELY WILL INFORM FDA. IF NO FURTHER INFORMATION IS BECOMING AVAILABLE, MFR CONSIDERS THIS FILE AS CLOSED. AFTER CONCLUSION OF THE DATA, WE ASSUME THAT THE SPROTTE CANNULA WAS BENT OR KINKED MASSIVELY BY LOCAL CONDITIONS (E.G. PRE-DAMAGE BY BONE CONTACT) OR DUE TO PHYSIOLOGICAL CHARACTERISTICS OF THE PATIENT AND IS THEREFORE BROKEN ULTIMATELY AT THE EXIT POINT OF THE INTRODUCER CANNULA. A PRODUCT FAILURE CANNOT BE CONFIRMED WITH THE AVAILABLE DATA.

    Description of Event or Problem · 1

    (B)(4). EVENT TOOK PLACE IN (B)(4) AND HAS BEEN REPORTED TO NATIONAL HEALTH AUTHORITIES. DESCRIPTION OF THE CUSTOMER: YESTERDAY ON AN OBESE AND SOMEWHAT UNCOOPERATIVE PATIENT FOR AN ACUTE CESAREAN SECTION, I USED A PAJUNK SPROTTE CANNULA 25G 90MM. WITHOUT VIOLENT BEHAVIOR ON MY PART, THE CANNULA BROKE. I DID NOT FEEL THIS AS A SNAP BUT RATHER UNDERSTOOD WHAT HAD HAPPENED WHEN RETRACTING THE NEEDLE OUT OF THE INTRODUCER FOR ANOTHER TRY. I HAD HIT BONE ON MY SEARCH FOR THE INTRATHECAL SPACE BUT NOT WITH ANY FORCE. THE CANNULA BROKE AT THE POINT WHERE IT LEAVES THE INTRODUCER, QUITE POSSIBLY I BENT IT HERE. I DID NOT REDIRECT THE INTRODUCER WITH THE CANNULA TIP DISTAL OF THE INTRODUCER. I HAVE PERFORMED OVER 800 CENTRAL AXIAL BLOCKS. I GOT A NEW NEEDLE, SUCCESSFULLY SPINALIZED THE MOTHER AND A HEALTHY CHILD WAS BORN IN A FEW MINUTES. AFTER THE SURGERY, STILL IN THE THEATRE, A CONSULTANT ANESTHETIST EXTRACTED THE CANNULA BY MEANS OF X-RAY, SCALPEL, FORCEPS AND SOME ADDED XYLOCAINE WHEN THE SPINAL STARTED TO WEAR OFF. THE MOST SHALLOW PART OF THE NEEDLE WAS 2CM DEEP OF THE PATIENT'S SKIN SURFACE:.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432191 SPROTTE 868.5150 ANETHESIA CONDUCTION NEEDLE BSP PAJUNK GMBH MEDIZINTECHNOLOGIE 021151-29A 1042

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R