BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE, HYPODERMIC, SINGLE LUMEN

    MDR report key: 10476189 · Received September 1, 2020

    Report

    Report Number
    3003902955-2020-00030
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    July 22, 2020
    Report Date
    September 1, 2020
    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

    PATIENT IDENTIFIER - REQUESTED, NOT PROVIDED. AGE & DATE OF BIRTH - REQUESTED, NOT PROVIDED. SEX - REQUESTED, NOT PROVIDED. WEIGHT - REQUESTED, NOT PROVIDED. ETHNICITY - REQUESTED, NOT PROVIDED. RACE - REQUESTED, NOT PROVIDED. BRAND NAME - SG3+2238 & SG3+2151: TERUMO SURGUARD3 HYPODERMIC NEEDLE AND SG3+2325: TERUMO SURGUARD3 SAFETY HYPODERMIC NEEDLE (SHORT SHEATH). CATALOG NUMBER- POTENTIAL CATALOG NUMBERS: SG3+2238 ; SG3+2151 ; SG3+2151 ; SG3+2325. LOT NUMBER - POTENTIAL LOT MUMNERS :180608C ; 180516C ; 180517C ; 180528D. EXPIRATION DATE - POTENTIAL DATES : MAY 31, 2023 ; APRIL 30, 2023 ; APRIL 30, 2023 ; APRIL 30, 2023. UDI - POTENTIAL UDI'S (B)(4). IMPLANTED DATE: DEVICE WAS NOT IMPLANTED. EXPLANTED DATE: DEVICE WAS NOT EXPLANTED. DEVICE MANUFACTURE DATE - POTENTIAL DATES: JUNE 8, 2018 ; MAY 16, 2018 ; MAY 17, 2018 ; MAY 28, 2018. OCCUPATION - QA COMPLIANCE SPECIALIST. PMA/510(K) - POTENTIAL NUMBERS SG3+2238 & SG3+2151: K113422, SG3+2325: K122249. BASED FROM THE RESULTS OF OUR INVESTIGATION THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE IDENTIFIED. ACTUAL SAMPLE WAS NOT RETURNED FOR EVALUATION HENCE WE COULD NOT PROVIDE THE DETAILED INFORMATION OF ITS ACTUAL CONDITION. RETENTION SAMPLES WERE CONFIRMED FREE FROM DEFECTS THAT WILL AFFECT ACTIVATION OF SAFETY SHEATH. RELATED FUNCTIONAL TESTING SUCH AS SHEATH ACTIVATION AND DEACTIVATION WERE ALL PASSED. IN ADDITION, SIMULATION OF SAFETY SHEATH MANUAL ACTIVATION WAS SUCCESSFULLY DONE AND NO DIFFICULTY OR IRREGULARITY ON ACTIVATION WAS ENCOUNTERED. WE HAVE SERIES OF VISUAL IN-PROCESS INSPECTION TO DETECT ABNORMALITY ON THE SHEATH THAT MAY LEAD TO PROBLEM DURING SHEATH ACTIVATION. MOLDING CONDITION OF THE COMPONENTS CRITICAL TO THE SAFETY ACTIVATION OF THE PRODUCT IS ROUTINELY CHECKED TO ASSURE THAT NO DEFECTS WILL BE ENCOUNTERED THAT WILL LEAD TO SHEATH ACTIVATION PROBLEM. SIMILARLY, THE ASSEMBLY STATUS OF THE SAFETY NEEDLE SUCH AS SHEATH COLLAR FITTING AND DAMAGED PARTS THAT WILL AFFECT PRODUCT FUNCTION IS BEING CONFIRMED. PRIOR SHIPMENT, QC CONDUCTS OUTGOING VISUAL, SENSORY, AND FUNCTIONAL INSPECTION TO ASSURE LOTS ARE IN GOOD QUALITY. WE HAVE PROPER INSTRUCTION FOR USAGE OF SG3 NEEDLE THAT IS ADDRESSED IN THE IFU AS PROVIDED IN THE LEAFLET IN WHICH WARNINGS, CAUTIONS AND PRECAUTIONS ARE INDICATED. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE PROTECTION MECHANISM OF THE CANNULA WAS USED AFTER THE INJECTION WAS ADMINISTERED BUT DID NOT APPEAR TO HAVE LOCKED. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944681 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO PHILIPPINES CORPORATION N/A

    Patients

    Seq Age Sex Outcome Treatment
    1