BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGUARD2 SAFETY NEEDLE

    MDR report key: 4163472 · Received October 10, 2014

    Report

    Report Number
    3003902955-2014-00020
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    July 17, 2014
    Report Date
    October 10, 2014
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    MEG
    PMA / PMN Number
    K051865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS NOT RETURNED FOR EVALUATION. VISUALLY INSPECTION OF RETENTION AND CURRENT LOT SAMPLES DID NOT REVEAL ANY DEFECTS OR ABNORMALITIES. FUNCTION TESTING CONFIRMED THAT PERFORMANCE SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THERE WERE NO PRODUCTION RELATED PROBLEMS. ALTHOUGH THE CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED UPON THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. 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: (1) "HANDLE WITH CARE TO AVOID NEEDLESTICKS"; (2) "KEEP HANDS BEHIND THE NEEDLE AT ALL TIMES DURING USE AND DISPOSAL"; (3) "FOR GREATEST SAFETY, ACTIVATE THE SHEATH USING A ONE-HANDED TECHNIQUE"; (4) "IF A NEEDLE IS BENT OR DAMAGED, NO ATTEMPT SHOULD BE MADE TO STRAIGHTEN NEEDLE OR USE THE PRODUCT"; (5) "POSITION SHEATH APPROXIMATELY 45 DEGREES TO A FLAT SURFACE. PRESS DOWN WITH A FIRM, QUICK MOTION UNTIL A DISTINCT AUDIBLE CLICK IS HEARD"; (6) "VISUALLY CONFIRM THAT THE NEEDLE IS FULLY ENGAGED UNDER THE LOCK"; AND (7) "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 FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AND THE INVESTIGATION HAS YET TO BE COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    (B)(4)

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED A NEEDLE STICK DUE TO SAFETY DEVICE NOT ENGAGED. FOLLOW-UP COMMUNICATION WITH THE USER FACILITY CONFIRMED; (1) THE NURSE WAS ADMINISTERING TDAP; (2) THE NURSE ATTEMPTED TO LOCK THE SAFETY CAP USING THE TABLE TOP; (3) A CLICK WAS HERD CLICK AND DEVICE WAS PUT IN THE SINK; (4) THE NURSE WENT BACK SHE FOUND THE DEVICE NOT ENGAGED AND STUCK HERSELF; (5) THE NURSE STATED THE NEEDLE WAS BENT SIDEWAYS, BUT WAS NOT PROTRUDING THROUGH THE CAP; AND (5) THERE WAS NO ISSUES AS A RESULT OF NEEDLE STICK.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639530 SURGUARD2 SAFETY NEEDLE TERUMO NEOLUS NEEDLE MEG TERUMO PHILIPPINES CORPORATION NA 130930B

    Patients

    Seq Age Sex Outcome Treatment
    1