BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL ADAPTER

    MDR report key: 15465041 · Received September 22, 2022

    Report

    Report Number
    3000223297-2022-00004
    Event Type
    Malfunction
    Date Received
    September 22, 2022
    Date of Event
    November 24, 2021
    Report Date
    September 21, 2022
    Manufacturer
    WEST PHARMA. SERVICES, IL LTD
    Product Code
    LHI
    PMA / PMN Number
    K963583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL INVESTIGATIONS INDICATE THAT LOT E188 WAS MANUFACTURED, INSPECTED ACCORDING TO RELEVANT PROCEDURES TESTED BEFORE RELEASE AND SHIPPED ACCORDING TO SPECIFICATIONS. LOT E188 WAS SEALED BY AN FFS SEALING MACHINE (WEST'S SUB-CONTRACTOR) AND COMPRISED OF 62,308 UNITS. DOM: AUG-2020. BATCH RECORD FOR LOT E188 WAS REVIEWED BY QA SPECIALIST ON (B)(6) 2021 NO NCM'S WERE FOUND. ALL QC INSPECTIONS INCLUDING VISUAL INSPECTIONS WERE CONDUCTED ACCORDING TO THE PROCEDURES, NO ISSUES WERE NOTICED. RETAINED SAMPLES FROM LOT E188 WERE 100% INSPECTED ACCORDING TO RELEVANT SOP BY THE SUB-CONTRACTOR, NO ISSUES WERE OBSERVED. ACCORDING TO THE WEST'S SUB-CONTRACTOR, THE MOST PROBABLE ROOT CAUSE IS RELATED TO THE MACHINE, AS THE GREASE RESIDUES WHICH NORMALLY LAYS ON THE GEAR, WERE ACCIDENTALLY RELEASED AND ENCOUNTERED THE PETG RIGHT AFTER THE FORMING STAGE AND BEFORE THE SEALING OF THE PRODUCT. A TRAINING WAS PERFORMED BY THE QA MANGER SUB-CONTRACTOR TO ALL RELEVANT PERSONNEL REGARDING THIS COMPLAINT AWARENESS.

    Description of Event or Problem · 0

    ON (B)(6) 2021, BAYER CONTACTED WEST PHARMA. SERVICES IL, LTD. (WEST) TO REPORT FOREIGN MATERIAL ADHERED TO THE INSIDE OF THE SEALED PACKAGING OF THE VIAL ADAPTER (PARTICULATE CONTAMINATION) PRIOR TO USE IN WEST TG 8072108 CE MRK, VENDOR BATCH E188, BAYER BATCH 2712W08. THIS DISCREPANCY WAS FOUND DURING PACKAGING ON ONE (1) VIAL ADAPTER OUT OF 5515 INSPECTED. PHOTOGRAPHS FROM THE CUSTOMER ARE AVAILABLE UPON REQUEST. THIS COMPLAINT WAS INITIALLY DETERMINED NON-REPORTABLE, BUT IT HAS BEEN RE-ASSESSED AND DEEMED REPORTABLE RETROSPECTIVELY AS OF 9/14/2022 DUE TO A SECOND COMPLAINT RECEIVED ON THE SAME LOT, E188(3000223297-2022-00002).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2662506 VIAL ADAPTER VIAL ADAPTER LHI WEST PHARMA. SERVICES, IL LTD E188

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown