BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE, HYPODERMIC, SINGLE LUMEN

    MDR report key: 9294974 · Received November 8, 2019

    Report

    Report Number
    3003902955-2019-00043
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    September 26, 2019
    Report Date
    November 8, 2019
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME - FOR SG3+2151, SG3+2238 - TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE AND SG3+2325 - TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE (SHORT SHEATH). CATALOG NUMBER- POTENTIAL CATALOG NUMBERS: SG3+2151, SG3+2325, AND SG3+2238. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K) - FOR SG3+2151, SG3+2238 - K113422, SG3+2325 - K122249. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO LOT NUMBER BEING UNKNOWN. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE IDENTIFIED. LOT HISTORY FILE AND RETENTION SAMPLES WERE UNABLE TO CONFIRM SINCE LOT NUMBER OF THIS COMPLAINT IS UNKNOWN. SIMULATION WAS CONDUCTED ON REPRESENTATIVE SAMPLES OF SAME PRODUCT, NEEDLE GAUGE AND LENGTH INVOLVED. THE SAFETY NEEDLE WAS CONNECTED AND SECURELY TIGHTENED TO THE SYRINGE THEN MANUAL SHEATH ACTIVATION WAS CONDUCTED USING THREE MODES; THUMB, FINGER AND HARD SURFACE. AN AUDIBLE CLICK WAS HEARD INDICATING SUCCESSFUL SAFETY ACTIVATION. NEEDLE WAS ENGAGED TO SAFETY SHEATH WITHOUT DIFFICULTY OR ANY IRREGULARITY. MOLDING CONDITION OF THE COMPONENTS CRITICAL TO THE SAFETY ACTIVATION AND CONNECTION OF THE PRODUCT IS CHECKED TO ASSURE THAT NO DEFECTS WILL BE ENCOUNTERED THAT WILL LEAD TO SHEATH ACTIVATION PROBLEM. WE HAVE IN-PROCESS INSPECTION FOR VISUAL, SENSORY, AND FUNCTIONAL TEST TO ASSURE QUALITY PERFORMANCE OF ASSEMBLED SG3 NEEDLE. PRIOR SHIPMENT, QC CONDUCTS OUTGOING INSPECTION TO ASSURE LOTS ARE IN GOOD QUALITY. ONLY SAMPLES PASSED SPECIFICATION ARE ALLOWED TO BE SHIPPED. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT A NURSE PRICKED HER FINGER WITH THE NEEDLE OF ABILIFY MAINTENA, WANTING TO PUT BACK THE PROTECTION. SHE PUT THE SHEATH, BUT THE NEEDLE HAD TO DEVIATE FROM THE GUIDE BECAUSE THIS ONE WAS TOO SOFT OR PROBABLY OUT OF PLACE/MIS-FRAMED. THE NURSE HAD TESTING DONE. THE NURSE WAS HEALTHY, AND SHE HAS NO PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090179 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO PHILIPPINES CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1