BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL ADAPTER

    MDR report key: 19520328 · Received June 12, 2024

    Report

    Report Number
    3000223297-2024-00002
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 8, 2024
    Report Date
    July 18, 2025
    Manufacturer
    WEST PHARMA SERVICES IL, LTD
    Product Code
    LHI
    UDI-DI
    07290108240412
    PMA / PMN Number
    K963583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WEST PHARMA. SERVICES IL, LTD. (WEST IL) IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE HAS NOT YET BEEN RETURNED TO WEST IL FOR AN EVALUATION. HOWEVER, A PHOTOGRAPH WAS PROVIDED TO WEST IL WITH VISIBLE PARTICLES AS REPORTED INSIDE OF THE PACKAGED DEVICE. 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

    THE RETURNED SAMPLES WERE RECEIVED AT THE MANUFACTURER AND WERE INSPECTED. ACCORDING TO THE INSPECTION OF THE RECEIVED SAMPLES, FREE BLUE FOREIGN MATERIAL WAS FOUND INSIDE BOTH SEALED PRODUCTS. THE REPORTED ISSUE OF PARTICLES INSIDE THE PRODUCT WAS VERIFIED. AN OFFICIAL SUPPLIER COMPLAINT WAS SENT TO THE CONTRACT MANUFACTURER WITH THE SAMPLES AND REQUEST FOR INVESTIGATION. ACCORDING TO THE CONTRACT MANUFACTURER'S REPORT, THE BATCH RECORDS FOR LOT# F700 WERE REVIEWED, NO ISSUES WERE REPORTED. IN-PROCESS AND FINAL INSPECTION OF PRODUCTS WAS PERFORMED; NO ISSUES WERE FOUND. THEREFORE, THE ROOT CAUSE WAS DETERMINED TO BE DUE TO ENVIRONMENTAL FACTORS DURING THE MANUFACTURING PROCESS. THE PARTICLES CAN BE FROM RAW MATERIALS, OPERATORS, OR AIR VENTILATION WHEN MANUFACTURED. NO CORRECTIVE ACTION FROM THE MANUFACTURER IS REQUIRED. HOWEVER, AS A CORRECTIVE ACTION, THE CONTRACT MANUFACTURER IMPLEMENTED TRAINING FOR ALL RELEVANT EMPLOYEES REGARDING THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    UNIQUE DEVICE IDENTIFIER (UDI) # CORRECTED. COMPLAINT IS CURRENTLY BEING INVESTIGATED BY MANUFACTURER. UPON COMPLETION OF THE INVESTIGATION AND IF ADDITIONAL INFORMATION IS PROVIDED FROM THE MANUFACTURER'S CUSTOMER A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON 13MAY2024, THE CUSTOMER, FERRING PHARMACEUTICALS, CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL), TO REPORT THAT DURING ASSEMBLY OF FERRING'S COMBINATION PACK, A VIAL ADAPTER, WAS OBSERVED WITH A BLUE FOREIGN PARTICULATE MATTER WITHIN THE PRIMARY STERILE PACKAGE. SUBSEQUENTLY, THE CUSTOMER OBSERVED A SECOND VIAL ADAPTER WITH ANOTHER BLUE FOREIGN PARTICULATE MATTER WITHIN THE PRIMARY STERILE PACKAGE. BOTH VIAL ADAPTERS ARE FROM LOT # F700. THE WEST PHARMA. VIAL ADAPTERS ARE CO-PACKED WITH THE DRUG FIRMAGON, THIS MEDICATION IS TO BE ADMINISTERED SUBCUTANEOUSLY AS AN INJECTION. BATCH RECORDS FOR LOT# F700 WERE REVIEWED AND THERE WERE NO NON CONFORMANCES FOUND. QUALITY CONTROL INSPECTIONS WERE CONDUCTED ACCORDING TO PROCEDURES DURING PRODUCTION, NO ISSUES WERE NOTICED. THE INCOMING INSPECTION RECORDS OF THE TYVEK AND NEEDLES WERE REVIEWED, NO ISSUES WERE NOTICED. LOT #F700 WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES TESTED BEFORE RELEASE AND SHIPPED ACCORDING TO SPECIFICATIONS. RETAINED SAMPLES FROM LOT #F700 WERE 100% VISUALLY INSPECTED BY THE CONTRACT MANUFACTURER ACCORDING TO THEIR INTERNAL PROCEDURE, NO FINDINGS WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546443 VIAL ADAPTER VIAL ADAPTER 20MM FLL W/ RIBS LHI WEST PHARMA SERVICES IL, LTD F700 07290108240412

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown