BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO NEEDLE

    MDR report key: 15921376 · Received December 5, 2022

    Report

    Report Number
    3003902955-2022-00059
    Event Type
    Malfunction
    Date Received
    December 5, 2022
    Date of Event
    October 31, 2022
    Report Date
    December 5, 2022
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K121607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE: 2027-02. IMPLANTED DATE: NO PATIENT INVOLVEMENT. EXPLANTED DATE: NO PATIENT INVOLVEMENT. INITIAL REPORTER NAME: MR./MS. (B)(6). THE ACTUAL SAMPLE AND REFERENCE PHOTOS WERE RECEIVED FOR EVALUATION. REFERENCE PHOTOS WERE INITIALLY PROVIDED BY TC SHOWED AN ASSEMBLED NEEDLE WITHOUT A BLISTER PACKAGE. A BLACK FOREIGN MATERIAL WAS OBSERVED ON THE INNER SURFACE OF THE PROTECTOR. BASED ON THE EDX RESULT, THE FOREIGN MATERIAL WAS PRESUMED TO BE METAL OXIDE WHICH MEASURES 0.0024MM2. THE ACTUAL SAMPLE RECEIVED WHEREIN NO FOREIGN MATERIAL WAS OBSERVED ON THE PROTECTOR SINCE IT WAS ALREADY SUBJECTED TO EDX ANALYSIS. RETENTION SAMPLES WERE VISUALLY INSPECTED AND CONFIRMED FREE FROM ANY FOREIGN MATERIAL THAT COULD LEAD TO THE COMPLAINT. THE REVIEW OF THE COMPLAINT MASTERFILE SHOWED THAT THIS IS THE FIRST TIME WE RECEIVED A COMPLAINT RELATED TO FOREIGN MATERIAL (METAL OXIDE). AS CORRECTIVE ACTION PH-PQD-NN006 NN ASSEMBLY CLEANING WORK INSTRUCTION HAS BEEN REVISED ON (B)(6) 2022, TO INCLUDE THE CLEANING BETWEEN THE AGITATOR SHAFT AND AGITATOR PLATE. THE ROOT CAUSE OF THIS COMPLAINT ORIGINATED IN OUR PRODUCTION PROCESS. BASED ON RECORDS, AN ACTIVITY WAS CONDUCTED AT THE PROTECTOR STATION LAST SEPTEMBER 23, 2021, WHEREIN THE AGITATOR WING WAS DISASSEMBLED AND REASSEMBLED. POSSIBLY THE BOLT WAS OVER-TIGHTENED ON THE AGITATOR PLATE DURING THE INSTALLATION OF THE AGITATOR WING WHICH RESULTED TO METAL-TO-METAL CONTACT BETWEEN THE BOLT LOCK AND THE AGITATOR SHAFT. THE METAL-TO-METAL CONTACT CREATES THE FOREIGN MATERIAL STUCK IN BETWEEN THE AGITATOR SHAFT AND THE AGITATOR PLATE WHICH EVENTUALLY ACCUMULATES AND FELL INSIDE THE PROTECTOR DUE TO THE MACHINE'S VIBRATION. WE HAVE MACHINE MAINTENANCE CLEANING EVERY WEEK HOWEVER, THE CLEANING BETWEEN THE AGITATOR SHAFT AND THE HOPPER INNER WALL WAS NOT SPECIFIED IN THE PROCEDURE. AS CORRECTIVE ACTION PH-PQD-NN006 NN ASSEMBLY CLEANING WORK INSTRUCTION HAS BEEN REVISED ON NOVEMBER 30, 2022, TO INCLUDE THE CLEANING BETWEEN THE AGITATOR SHAFT AND HOPPER INNER WALL. BEFORE SHIPMENT QC CONDUCTS AN OUTGOING INSPECTION TO CHECK THE CONDITION OF THE PRODUCT. ALL SAMPLES PASSED. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO: (B)(4) IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO (B)(4) CORPORATION (MANUFACTURER) REGISTRATION NO: (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT A NURSE FOUND FOREIGN MATERIAL WITH THE INVOLVED TERUMO NEEDLE DURING PREPARATION. THIS WAS NOTICED AFTER THE INDIVIDUAL PACKAGE WAS OPENED AND BEFORE THE PROTECTOR WAS REMOVED. SINCE THE BLACK DOT WAS FOUND INSIDE THE PROTECTOR, THE USER DIDN'T USE THIS DEVICE. TC RECEIVED THE ACTUAL SAMPLE ON (B)(6) 2022. (B)(6) CONFIRMED THAT A BLACK FOREIGN MATERIAL WAS INSIDE THE PROTECTOR. THE FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) RESULT SHOWED THAT THE FOREIGN MATERIAL WAS PRESUMED TO BE A METAL OXIDE. THE EVENT OCCURRED PRE-TREATMENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112594 TERUMO NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO PHILIPPINES CORPORATION N/A 220309C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown