BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO SURGUARD2 SAFETY NEEDLE

    MDR report key: 2851337 · Received November 29, 2012

    Report

    Report Number
    3003902955-2012-00012
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K051865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE IS REPORTEDLY NOT AVAILABLE FOR RETURN TO THE MANUFACTURING FACILITY FOR EVALUATION AND THE LOT NUMBER IS NOT KNOWN. THEREFORE, THE INVESTIGATION WAS LIMITED TO EVALUATION OF UNUSED RETENTION SAMPLES FROM REPRESENTATIVE LOTS. THOROUGH EXAMINATION AND TESTING OF THE UNUSED SAMPLES CONFIRMED: NO ABNORMALITIES OR DEFECTS WERE NOTED ON VISUAL INSPECTION; AND ALL COMPONENTS WERE PROPERLY ASSEMBLED. THERE IS NO INDICATION THAT THERE WAS ANY RELATION TO A PRE-EXISTING DEVICE DEFECT. ALTHOUGH THE CAUSE FOR THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION, THE EVENT DESCRIPTION IS MOST CONSISTENT WITH USING IMPROPER TECHNIQUE IN TRYING TO ACTIVATE THE SAFETY FEATURE. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN OCCURRENCE IN THE WARNINGS/CAUTIONS AND THE INSTRUCTIONS-FOR-USE WITH STATEMENTS TO MINIMIZE THE POTENTIAL FOR A NEEDLESTICK SUCH AS THE FOLLOWING: "HANDLE WITH CARE TO AVOID NEEDLESTICKS"; "IF A NEEDLE IS BENT OR DAMAGED, NO ATTEMPT SHOULD BE MADE TO STRAIGHTEN NEEDLE OR USE THE PRODUCT"; "KEEP HANDS BEHIND THE NEEDLE AT ALL TIMES DURING USE AND DISPOSAL"; "FOR GREATEST SAFETY, ACTIVATE THE SHEATH USING A ONE-HANDED TECHNIQUE"; "POSITION SHEATH APPROXIMATELY 45 DEGREES TO A FLAT SURFACE. PRESS DOWN WITH A FIRM, QUICK MOTION UNTIL A DISTINCT AUDIBLE CLICK IS HEARD"; "VISUALLY CONFIRM THAT THE NEEDLE IS FULLY ENGAGED UNDER THE LOCK"; AND "DISPOSE OF USED NEEDLES AND MATERIALS FOLLOWING THE POLICIES AND PROCEDURES OF YOUR FACILITY AS WELL AS FEDERAL AND LOCAL REGULATIONS FOR SHARPS DISPOSAL." ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A STAFF MEMBER INCURRED A NEEDLE-STICK WHILE ATTEMPTING TO ACTIVATE THE SAFETY FEATURE FOLLOWING AN INJECTION. DURING FOLLOW-UP COMMUNICATION WITH THE USER FACILITY IT WAS STATED THAT THE SAFETY MECHANISM "DID NOT ENGAGE" RESULTING IN A NEEDLE-STICK TO THE USER. NO ADDITIONAL EVENT SPECIFIC INFORMATION COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO SURGUARD2 SAFETY NEEDLE SAFETY NEEDLE FMI TERUMO PHILIPPINES CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1