BEUDAMED
    FDA Adverse Event Other Summary report: N

    STANDARD SPROTTE NEEDLE

    MDR report key: 745075 · Received July 27, 2006

    Report

    Report Number
    9611612-2006-00002
    Event Type
    Other
    Date Received
    July 27, 2006
    Date of Event
    April 4, 2006
    Report Date
    July 21, 2006
    Manufacturer
    PAJUNK GMBH
    Product Code
    BSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN PUNCTURED WITHOUT STYLET, FOLLOWED BY STRONG BONE CONTACT. THIS LED TO SPINAL CANNULA BREAKAGE APPROX. AT THE END OF THE INTRODUCER CANNULA TIP. THE STYLET WAS RETURNED TOTALLY STRAIGHT (BECAUSE IT WAS NOT USED). SUCH CANNULA USED WITHOUT A STYLET WITHIN THE SPINAL CANNULA CAN LEAD TO CANNULA BREAKAGE IN CASE OF BONE CONTACT. THE NEEDLE WAS SENT BACK TO MFR AND WAS EVALUATED VIA MICROSCOPE: STRONG BONE CONTACT OBVIOUSLY CAUSED A BREAKAGE OF THE NEEDLE BECAUSE, THE PHYSICIAN DID NOT USE THE STYLET FOR REINFORCEMENT OF THE NEEDLE AS REQUIRED. IN THE OPERATING INSTRUCTIONS IT'S STATED: BENDING OF THE CANNULA-TIP CAN BE SAFELY AVOIDED BY NOT USING FORCE UPON CONTACT WITH BONE. AS WELL, THE MANDARIN SHOULD BE POSITIONED INSIDE THE SHAFT." MULTIPLE CONTACT WITH BONES DAMAGES THE TIP RESULTING IN A TRAUMATIC PUNCTION"... "ATTEMPTS TO OVER POWER THE RESISTANCE OF THE BONE MUST BE AVOIDED. FAILURE TO DO THIS MAY BEND THE CANNULA TIP. THE STABILITY THEN IS JUST SUFFICIENT TO REMOVE THE CANNULA WITHOUT BREAKING OFF THE TIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD SPROTTE NEEDLE STANDARD SPROTTE NEEDLE BSP PAJUNK GMBH 021151-29A 653

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention