BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    MDR report key: 8064673 · Received November 13, 2018

    Report

    Report Number
    3003902955-2018-00045
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    October 11, 2018
    Report Date
    November 13, 2018
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K113422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BRAND NAME - TERUMO SURGUARD 3 SAFETY HYPODERMIC NEEDLE - SG3+2151, SG3+2125, SG3+2238 OR TERUMO SURGUARD 3 SAFETY. HYPODERMIC NEEDLE (SHORT SHEATH) - SG3+2325. CATALOG NUMBER- POTENTIAL PRODUCT CODE: SG3+2151, SG3+2125, SG3+2238 OR SG3+2325. LOT NUMBER - POTENTIAL LOT NUMBERS: 160804C, 160805C, 160718D AND 160719D. (B)(4). EXPIRATION DATE - (1) 160804C, 07-2021 (2) 160805C, 07-2021 (3) 160718D, 06-2021 (4) 160719D, 06-2021. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. OCCUPATION - GLOBAL PRODUCT QUALITY COMPLAINTS. PMA/510(K) - K113422 FOR SG3+2151, SG3+2125, SG3+2238 AND K122249 FOR SG3+2325. DEVICE MANUFACTURE DATE - (1) 160804C, 04-AUG-2016 (2) 160805C, 05-AUG-2016 (3) 160718D, 18-JUL-2016 (4) 160719D, 19-JUL-2016. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED UPON EVALUATION OF USER FACILITY INFORMATION AND RETENTION SAMPLES. BASED ON THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE OF THE PROBLEM COULD NOT BE IDENTIFIED SINCE CONDITION OF THE ACTUAL SAMPLE WAS NOT CONFIRMED. RETENTION SAMPLES WERE VISUALLY CHECKED FOR ANY PRESENCE OF DEFECTS ON SHEATH, COLLAR AND MOLDING RELATED DEFECTS SUCH AS CRACK, HOLES, OR SHORT SHOT THAT ARE CRITICAL TO THE ACTIVATION OF THE PRODUCT. NO DEFECT WAS NOTED ON ALL SAMPLES. RETENTION SAMPLES PASSED THE SHEATH ACTIVATION AND DEACTIVATION AND SHEATH RADIAL STRENGTH AND SIMULATION CONDUCTED SHOWED THE CANNULA IS SECURELY LOCKED INTO THE SHEATH AND THE SAFETY SHEATH DID NOT FALL OFF FROM COLLAR. WE HAVE IN-PROCESS INSPECTION FOR VISUAL, SENSORY, AND FUNCTIONAL TEST TO ASSURE QUALITY PERFORMANCE OF ASSEMBLED NEEDLE. PRIOR SHIPMENT, QC CONDUCTS OUTGOING INSPECTION TO ASSURE LOTS ARE IN GOOD QUALITY. ALL SAMPLES PASSED. WITH NO DEVICE RETURN, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO (PHILIPPINES) CORPORATION (MANUFACTURER) REGISTRATION NO. 3003902955. EXEMPTION NUMBER E2015017.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT PATIENT WAS GIVEN AN INJECTION. WHEN THE NURSE TRIED TO PUT THE SAFETY CAP ON, IT FELL OFF. THE SAFETY COVER USED TO CAP THE USED NEEDLE ON THE DUAL CHAMBERED SYRINGE, FELL OFF. ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 16, 2018: IT WAS REPORTED THAT THEY HAD NO PROBLEMS AT ALL PREPARING AND INJECTING THE SCHEDULED DOSE INTO THE PATIENT WITH THE KIT. THE PROBLEM OCCURRED AFTER THE DOSE ADMINISTRATION WHEN ATTEMPTING TO ENGAGE THE NEEDLE SHIELD AND GETTING READY TO DISPOSE OF THE SYRINGE. WHEN THE NURSE ATTEMPTED TO ENGAGE THE NEEDLE SHIELD, IT "FELL OFF". IT WAS SPECIFIED THAT THE SHIELD DID NOT CRACK IT JUST SEEMED TO FALL OFF THE NEEDLE. THERE WAS NO DAMAGE NOTED ON ANY OF THE PACKAGING PRIOR TO PREPARATION AND ADMINISTRATION OF THE DOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906267 TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO PHILIPPINES CORPORATION N/A

    Patients

    Seq Age Sex Outcome Treatment
    1