BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO SURGUARD2 SAFETY HYPODERMIC NEEDLE

    MDR report key: 2142714 · Received June 17, 2011

    Report

    Report Number
    3003902955-2011-00009
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 13, 2011
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    MEG
    PMA / PMN Number
    K051865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION: BASED UPON TESTING OF RESERVE SAMPLES. THE INVOLVED SAMPLES HAVE NOT BEEN MADE AVAILABLE FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED UPON EVALUATION OF USER FACILITY INFORMATION, RETURNED UNUSED SAMPLES AND RESERVE SAMPLES. NO ABNORMALITIES OR DEFECTS WERE NOTED ON VISUAL INSPECTION AND ALL SAMPLES PASSED FUNCTIONAL TESTING. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS. A REVIEW OF THE COMPLAINT FILES CONFIRMED THAT THIS LOT NUMBER HAS NOT BEEN REPORTED PREVIOUSLY. THERE IS NO INDICATION THAT THERE WAS ANY RELATION TO A PRE-EXISTING DEVICE DEFECT. THE DEVICE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH AN OCCURRENCE IN THE WARNINGS/CAUTIONS AND THE INSTRUCTIONS-FOR-USE WITH STATEMENTS 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", "POSITION THE SHEATH APPROXIMATELY 45 DEGREES TO 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", "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 THE SAFETY FEATURE WOULD NOT LOCK ON SOME SAMPLES AND THE SAFETY SHIELD "BROKE OFF" DURING ATTEMPTS TO ENGAGE THE SAFETY FEATURE FOLLOWING USE OF ONE DEVICE. DURING FOLLOW-UP COMMUNICATION WITH THE USER FACILITY IT WAS CONFIRMED THAT: SPECIFIC PRODUCT CODES AND LOT NUMBERS WERE NOT NOTED DURING DEMONSTRATION OF SAFETY PRODUCT WITH THE DISTRIBUTOR REPRESENTATIVE; THE PRODUCT IDENTIFICATION INFORMATION WAS BASED ON CURRENT INVENTORY; AND NO ADDITIONAL EVENT SPECIFIC INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO SURGUARD2 SAFETY HYPODERMIC NEEDLE MEG TERUMO PHILIPPINES CORPORATION NA 100807

    Patients

    Seq Age Sex Outcome Treatment
    1 NA