BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE

    MDR report key: 7822701 · Received August 28, 2018

    Report

    Report Number
    3003902955-2018-00038
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    July 31, 2018
    Report Date
    August 28, 2018
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K113422
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OCCUPATION - QA COMPLIANCE SPECIALIST. BRAND NAME - TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE - SG3+2151, SG3+2238 OR TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE (SHORT SHEATH) - SG3+2325. CATALOG NUMBER- POTENTIAL PRODUCT CODE: SG3+2151, SG3+2238 OR SG3+2325 LOT NUMBER - REQUESTED, NOT PROVIDED. UDI - UNKNOWN DUE TO LOT NUMBER BEING UNKNOWN. EXPIRATION DATE - UNKNOWN DUE TO LOT NUMBER BEING UNKNOWN. IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. PMA/510(K) - K113422 FOR SG3+2151, SG3+2238 AND K122249 FOR SG3+2325. DEVICE MANUFACTURE DATE - UNKNOWN DUE TO COMPLAINT LOT NUMBER BEING UNKNOWN. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS BASED UPON EVALUATION OF USER FACILITY INFORMATION AND CURRENT LOT RETENTION SAMPLES. BASED FROM THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE OF THE PROBLEM COULD NOT BE IDENTIFIED. CURRENT LOT RETENTION SAMPLES WERE SUBJECTED TO MANUAL SHEATH ACTIVATION USING THE THREE MODES OF ACTIVATION: THUMB, FINGER AND HARD SURFACE ACTIVATION. THE SAFETY SHEATH WAS ACTIVATED WITH NO DIFFICULTY. 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. 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 THE INJECTION NURSE EXPERIENCED A NEEDLE STICK INJURY POST INJECTING A PATIENT. WHICH WAS A RESULT OF THE NEEDLE SAFETY CAP FAILURE TO LOCK CLOSED. THE NURSE STATED THAT THE PLASTIC COVER WAS FLIMSY AND THE HEALTH CARE PROVIDER HAS TO BE VERY CAREFUL AS THE NEEDLE CAN GO ON THE SIDE. THE NURSE STATED THAT THE QUALITY OF ABILIFY MAINTENA SYRINGES ARE NOT AS GOOD. IT WAS REPORTED AND HOSPITAL PROCEDURE WAS COMPLETED WITH NO ADVERSE EVENTS. THE NURSE AGREED TO LAB WORK AND THE RESULTS WERE ALL NEGATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON 8/16/2018: IT WAS REPORTED THAT ALL APPROPRIATE BLOOD WORK WAS COMPLETED ON THE NURSE AND ON THE PATIENT. A COMPLETE WORK UP WAS DONE FOR (B)(6) AND LIVER FUNCTION FOR A BASELINE ON THE NURSE AND ON THE PATIENT. ALL RESULTS WERE (B)(6) ON THE PATIENT AND THE NURSE IS IN GOOD HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662791 TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO PHILIPPINES CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1