BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGUARD2 SAFETY NEEDLE

    MDR report key: 4110751 · Received September 23, 2014

    Report

    Report Number
    3003902955-2014-00017
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 26, 2014
    Report Date
    September 23, 2014
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    MEG
    PMA / PMN Number
    K051865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS NOT RETURNED FOR EVALUATION. THE INVESTIGATION WAS BASED UPON ASSESSMENT OF USER FACILITY INFORMATION, EVALUATION OF REPRESENTATIVE SAMPLES AND CURRENT LOT SAMPLES. VISUAL INSPECTION OF REPRESENTATIVE AND CURRENT LOT SAMPLES DID NOT REVEAL ANY DEFECTS OR ABNORMALITIES. FUNCTION TESTING ON THE SAMPLES CONFIRMED THAT PERFORMANCE SPECIFICATIONS WERE MET. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED REVIEW OF APPLICABLE PRODUCTION OR COMPLAINT RECORDS. ALTHOUGH THE CAUSE FOR THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE EVENT WAS RELATED TO A PRE-EXISTING 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. (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A NURSE INCURRED A NEEDLE STICK. FOLLOW-UP COMMUNICATION WITH THE USER FACILITY CONFIRMED; (1) THE NURSE ACTIVATED THE SAFETY MECHANISM BY PULLING UP ON THE CAP TO ENGAGE IT; (2) SHE AND ANOTHER WORKER HEARD IT CLICK; (3) THE NURSE THEN PLACED THE DEVICE ON THE COUNTER WITH THE REST OF THE WRAPPERS OF TRASH; (4) WHEN THE NURSE WAS CLEANING UP SHE SCOOPED UP THE WRAPPER AND NEEDLE; (5) THIS WAS WHEN THE NURSE INCURRED A STICK WITH THE INFECTIOUS NEEDLE; AND (6) THE NURSE IS REPORTED DOING "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590321 SURGUARD2 SAFETY NEEDLE TERUMO NEOLUS NEEDLE MEG TERUMO PHILIPPINES CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1