BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO NEEDLE

    MDR report key: 13721141 · Received March 10, 2022

    Report

    Report Number
    3003902955-2022-00001
    Event Type
    Malfunction
    Date Received
    March 10, 2022
    Date of Event
    February 3, 2022
    Report Date
    March 10, 2022
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    FMI
    PMA / PMN Number
    K121607
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE: SEPTEMBER 2026. OPERATOR OF DEVICE - UNKNOWN. IMPLANTED DATE: NO PATIENT INVOLVEMENT. EXPLANTED DATE: NO PATIENT INVOLVEMENT. OCCUPATION - NOT PROVIDED, UNKNOWN. REFERENCE PHOTOS WERE RECEIVED FROM TC AND SHOWED A NEEDLE IN AN OPEN BLISTER PACKAGE WHEREIN, A BLACK FOREIGN MATTER WAS OBSERVED NEAR THE CANNULA TIP. THE RESULT OF THE FTIR AND EDX ANALYSIS RECEIVED FROM TC SHOWED THAT THE BLACK FOREIGN MATTER OBSERVED NEAR THE CANNULA TIP WAS COMPOSED OF SILICONE AND STAINLESS. TC CONFIRMED THAT THE FOREIGN MATTER ADHERED NEAR THE CANNULA TIP MEASURES 0.54MM2. BASED ON OUR INVESTIGATION, BLOCKAGE INSPECTION SENSOR ABNORMAL ALARM WAS ENCOUNTERED THAT RESULTED IN THE ACCUMULATION OF FOREIGN MATTER ON THE METAL WING AND METAL WING PARTITION GUIDE. THE TECHNICIAN CONDUCTED CLEANING AFTER THE ALARM OF THE MACHINE MOST LIKELY, THERE WAS A FOREIGN MATTER REMAINING ON THE METAL WING AND METAL WING PARTITION GUIDE. THIS ADHERED ACCUMULATED BLACK FOREIGN MATTER ON THE METAL WING AND METAL WING PARTITION WAS GRADUALLY PEELED-OFF AND DETACHED UPON CONTACTS OF JIGS DURING CONTINUOUS RUNNING. THIS FOREIGN MATTER TRANSFERRED ON THE JIG PATHWAY AND ON THE MACHINE PARTS WHICH EVENTUALLY DETACHED AND ADHERED ON CANNULA UPON AIR BLOWING. MOREOVER, BASED ON OUR PROCEDURE PH-PQD-NN030 NEEDLE ASSEMBLY INSPECTION WORK INSTRUCTION THERE SHOULD BE A PRODUCT CONFIRMATION OF A MINIMUM OF 3,000 PIECES WHEN BLOCKAGE TROUBLE WILL BE ENCOUNTERED. HOWEVER, THE INVOLVED ASSOCIATE CONFIRMED THAT THERE WAS NO PRODUCT CONFIRMATION ON THE AFFECTED JIGS SINCE HE HAD ALREADY TAKEN OUT THE AFFECTED JIG. THE FOLLOWING CORRECTIVE ACTIONS WERE AND WILL BE IMPLEMENTED TO ADDRESS THE ISSUE. REFRESHER TRAINING ON PH-PQD-NN030 NEEDLE ASSEMBLY INSPECTION WORK INSTRUCTION FOR THE FOLLOWING: DONE: (B)(6) 2022. IF THE ACTIVITY OF MACHINE CLEANING WAS CONDUCTED, PRODUCT CONFIRMATION FOR THE MINIMUM OF 3,000 PIECES OF THE PRODUCT WILL BE CONDUCTED ON THE AFFECTED BAG. CONDUCT PRODUCT DISSEMINATION TO ASSOCIATES THAT WHEN ENCOUNTER FREQUENT ALARM OF BLOCKAGE INSPECTION SENSOR ABNORMAL DUE TO ACCUMULATION OF FOREIGN MATTER ON THE METAL WING AND PARTITION, IMMEDIATELY REPORT TO MOI FIRST TO TAKE OUT THE METAL WING AND PARTITION AND CONDUCT PRODUCT CONFIRMATION AFTER THE ACTIVITY. CONDUCT PPR AWARENESS TO ASSOCIATE - DONE: FEBRUARY 20, 2022. NN ASSEMBLY COMMON TROUBLE ALARM MATRIX (NN1, NN2, NN3) MODULE WILL BE REVISED. IF ENCOUNTERED BLOCKAGE INSPECTION SENSOR ABNORMAL THE METAL WING AND PARTITION WILL BE TAKEN OUT. ALSO, CONDUCT CLEANING AND PRODUCT CONFIRMATION AFTER THE SAID ACTIVITY WAS ENCOUNTERED. TARGET DATE: (B)(6) 2022. THE CAUSE OF THE DEFECT CAME FROM OUR NEEDLE ASSEMBLY PROCESS. PRODUCT CONFIRMATION ON THE CURRENT RUNNING NN22X25UR40H/220211C AND NN22X32UR40H/220212GN WAS CONDUCTED WHEREIN NO SIMILAR DEFECT WAS FOUND ON 3,178 AND 15,029 PIECES RESPECTIVELY. BEFORE SHIPMENT OF PRODUCTS, QC CONDUCTS OUTGOING INSPECTION WHEREIN PART OF CHECK ITEMS IS FOREIGN MATTER ON CANNULA BODY. ALL SAMPLES PASSED. (B)(4).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT PRIOR TO USAGE, THE USER FOUND BLACK DIRT ON THE TIP OF THE TERUMO NEEDLE DEVICE. THE USAGE WAS DISCONTINUED. ADDITIONAL INFORMATION WAS RECEIVED ON 10 FEB 2022: BASED ON THE FTIR RESULT, THE FOREIGN MATTER ON THE NEEDLE WAS PRESUMED TO BE SILICONE AND STAINLESS STEEL. THE FOREIGN MATTER WAS NOT HARD TO REMOVE, IT WAS EASILY REMOVED WITH A TWEEZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1926501 TERUMO NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI TERUMO PHILIPPINES CORPORATION N/A 211006B

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown