BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIX2VIAL TRANSFER DEVICE

    MDR report key: 20919007 · Received December 12, 2024

    Report

    Report Number
    3000223297-2024-00010
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    November 13, 2024
    Report Date
    March 26, 2025
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD.
    Product Code
    LHI
    UDI-DI
    07290108240672
    PMA / PMN Number
    K031861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF BATCH RECORDS FOR LOT# J966 REVEALED NO NON-CONFORMANCE. ALL QC INSPECTIONS WERE CONDUCTED ACCORDING TO PROCEDURES, NO OTHER ISSUES WERE IDENTIFIED. ACCORDING TO THE MANUFACTURER'S RECORDS, LOT# J966 WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE, PACKED AND SHIPPED ACCORDING TO SPECIFICATIONS. COMPLAINTS DATABASE OF THE LAST THREE YEARS WAS REVIEWED; NO COMPLAINT WERE FOUND FOR THIS LOT. RETAINED SAMPLES FROM LOT#H275 WERE VISUALLY INSPECTED, NO FINDINGS WERE OBSERVED. ACCORDING TO THE THE SUB-MANUFACTURER'S REVIEW, NO ISSUES WERE NOTICED FOR THIS LOT. THERE IS NO CLEAR EVIDENCE THAT THE PRODUCT HAS BREACH IN STERILITY AS THE SAMPLES WERE NOT RETURNED TO THE MANUFACTURER FOR AN EVALUATION. THE MOST PROBABLE ROOT CAUSE OF THE DAMAGED SHIPPING BOX IS DUE TO IS MISHANDLING DURING STORAGE OR TRANSPORTATION. THERE IS NO INDICATION THAT THE DAMAGE WAS THE RESPONSIBILITY OF THE MANUFACTURER AS THE SHIPPING VENDOR SIGNED OFF ON THE RELEASED THE GOODS WITHOUT ANY DAMAGE. THEREFORE, NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 0

    COMPLAINT IS CURRENTLY BEING INVESTIGATED BY MANUFACTURER. THE DEVICE HAS NOT BEEN RETURNED FOR AN EVALUATION. HOWEVER, A PHOTOGRAPH WAS PROVIDED WITH VISIBLE DAMAGE TO THE SHIPPING BOX. 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 15NOV2024, THE CUSTOMER, PFIZER INC. CONTACTED THE MANUFACTURER TO REPORT THAT ONE (1) BOX CONTAINING A SHIPMENT OF 300 MIX2VIAL TRANSFER DEVICES, LOT# J966, WAS DELIVERED DAMAGED, EXPOSING THE DEVICES INSIDE THE BOX AND BREACHING STERILITY OF THE DEVICES. THERE WAS NO HEALTH IMPACT TO THE END USER AS THIS ISSUE WAS DETECTED PRIOR TO USE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2418253 MIX2VIAL TRANSFER DEVICE MIX2VIAL TRANSFER DEVICE LHI WEST PHARMA. SERVICES IL, LTD. J966 07290108240672

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown