BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL ADAPTER 20MM W/15UM FILTER TG -VF

    MDR report key: 17597321 · Received August 22, 2023

    Report

    Report Number
    3000223297-2023-00013
    Event Type
    Malfunction
    Date Received
    August 22, 2023
    Date of Event
    July 12, 2023
    Report Date
    January 21, 2025
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD
    Product Code
    LHI
    UDI-DI
    07290108240177
    PMA / PMN Number
    K963583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WEST IL IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE HAS NOT BEEN RETURNED TO WEST IL FOR AN EVALUATION. HOWEVER, A PHOTOGRAPH WAS PROVIDED TO WEST IL WHICH SHOWED THE INCOMPLETE BLISTER SEAL. UPON COMPLETION OF THE WEST IL INVESTIGATION AND IF ADDITIONAL INFORMATION IS PROVIDED FROM THE CUSTOMER, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A PRELIMINARY INVESTIGATION WAS PERFORMED BY WEST IL. ACCORDING TO WEST IL RECORDS, LOT# H666 WAS MANUFACTURED ACCORDING TO PROCEDURES, TESTED BEFORE RELEASE, SHIPPED ACCORDING TO SPECIFICATIONS AND SEALED BY AN AUTOMATIC FFS SEALING MACHINE. BATCH RECORDS FOR LOT# H666 WERE REVIEWED AND NO NCM'S WERE FOUND. ALL QC INSPECTIONS WERE CONDUCTED ACCORDING TO THE PROCEDURES, NO ISSUES WERE NOTICED. RETAINED SAMPLES FROM LOT# H666 WERE 100% INSPECTED BY THE SUBCONTRACTOR, NO ISSUES WERE OBSERVED. NINETY RETAINED SAMPLES OF LOT# H666 WERE VISUALLY INSPECTED BY WEST IL, ALL SAMPLES WERE FOUND INTACT. THE RETURNED SAMPLES WERE RECEIVED AT WEST IL AND INSPECTED. FROM THE RETURNED SAMPLES, A VIAL ADAPTER WAS OBSERVED TO BE IN A HALF-OPENED BLISTER, THE BLISTER WAS FLATTENED, DEFORMED. AN OFFICIAL SUPPLIER COMPLAINT WAS SENT TO THE CONTRACT MANUFACTURER WITH A REQUEST FOR INVESTIGATION. ACCORDING TO THE CONTRACT MANUFACTURER INVESTIGATION, THE BATCH RECORDS FOR THE MANUFACTURING OF THIS LOT WERE REVIEWED AND NO ISSUES WERE FOUND. MAINTENANCE LOGBOOK WAS CHECK AND ALL WAS FOUND INTACT FOR THIS PERIOD. IN PROCESS TESTING FOR DAMAGES IN TYVEK/BLISTER WAS PERFORMED FOR 3,971 PRODUCTS, AND FINAL TESTING WAS PERFORMED FOR 7,500 PRODUCTS, NO ISSUES WERE REPORTED. DEVIATIONS FROM PRODUCT'S HEIGHT WERE MONITORED, NO ISSUES WERE REPORTED. A SAMPLING OF 5,020 PRODUCTS WAS CONDUCTED FOR THE SEALING CRITERIA, NO ISSUES WERE REPORTED. THE BATCH RECORDS FOR CONSECUTIVE LOTS MANUFACTURED BEFORE AND AFTER LOT# H666 WERE REVIEWED, NO FINDINGS WERE FOUND REGARDING THIS REPORTED ISSUE. THE RETURN PROCESS HAS BEEN INITIATED AND IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED AND OR UPON COMPLETION OF THIS INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ACCORDING TO OUR INTERNAL INVESTIGATION OF LOT# H666 WAS MANUFACTURED ACCORDING TO THE RELEVANT PROCEDURE, TESTED BEFORE RELEASE, PACKED AND SHIPPED ACCORDING TO THE DEVICE SPECIFICATIONS. COMPLAINTS DATABASE OF THE LAST THREE YEARS WAS REVIEWED, NO JUSTIFIED COMPLAINTS WERE FOUND FOR THIS PRODUCT CAT# 8072112. RETAINED SAMPLES FROM LOT#H666 WERE 100% VISUALLY INSPECTED BY THE CM DURING PRODUCTION, PER PROCEDURE - NO FINDINGS WERE OBSERVED. ACCORDING TO THE SHIPPING VENDOR'S INVESTIGATION, THE SHIPMENT WAS SENT UNDER TEMPERATURE CONTROL 15-25 ALONG ALL THE SUPPLY CHAIN. DUE TO THE TIME THAT HAS PASSED, IT IS NOT POSSIBLE TO OBTAIN PRINTOUTS OF THE RECORDED TEMPERATURE SET IN THE TRUCKS OR WAREHOUSES. IT IS NOT POSSIBLE TO DETERMINE IF THE HEAT EXPOSURE OCCURRED PRIOR TO THE ARRIVAL OF THE GOODS IN BEN GURION AIRPORT OR AFTER THE DELIVERY OF THE GOODS AT THE CONSIGNEE WAREHOUSE. THE ROOT CAUSE OF THIS EVENT IS DUE TO INSUFFICIENT TEMPERATURE MONITORING OVER THE ENTIRE DOOR TO DOOR SHIPMENT PROCESS.

    Description of Event or Problem · 0

    ON (B)(6) 2023, BAYER, CONTACTED WEST PHARMACEUTICAL SERVICES, INC. (WEST), TO REPORT THAT DURING INCOMING INSPECTION OF THE WEST IL, VIAL ADAPTER, LOT H666, 1 OF 500 PRODUCTS HAS A VISIBLE INCOMPLETE BLISTER SEAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310564 VIAL ADAPTER 20MM W/15UM FILTER TG -VF VIAL ADAPTER 20MM W/15UM FILTER TG -VF LHI WEST PHARMA. SERVICES IL, LTD H666 07290108240177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown