BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL ADAPTER 13MM LONG W/25MIC FILTER-VF

    MDR report key: 17817781 · Received September 26, 2023

    Report

    Report Number
    3000223297-2023-00015
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    August 22, 2023
    Report Date
    December 12, 2023
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD
    Product Code
    LHI
    UDI-DI
    07290108240245
    PMA / PMN Number
    K963583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WEST PHARMA SERVICES IL (WEST IL) INVESTIGATED A COMPLAINT RECEIVED BY NOVO NORDISK, REGARDING OBSERVED BLACK PARTICLES WITHIN THE SEAL OF THE PACKAGED VIAL ADAPTER 13MM. THE AFFECTED SAMPLE WAS NOT RETURNED TO WEST IL FOR EVALUATION, THEREFORE, THE NATURE OF THE PARTICLE COULD NOT BE DETERMINED. ACCORDING TO A PHOTO PROVIDED BY THE CUSTOMER, THE REPORTED PARTICLE DOES NOT CROSS THE SEALING AREA AND NO PARTICLES WERE OBSERVED INSIDE THE BLISTER PACK. BATCH RECORDS REVIEW WAS PERFORMED ON LOT NUMBER F759 AND NO ISSUES WERE NOTICED. THIS LOT WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE, AND SHIPPED ACCORDING TO SPECIFICATIONS. RETAINED SAMPLES OF LOT NUMBER F759 WERE VISUALLY INSPECTED NO ISSUES WERE NOTICED. WEST IL SENT A FORMAL REQUEST FOR INVESTIGATION TO THE SUB-CONTRACTOR. ACCORDING TO THE SUB-CONTRACTOR, RETAINED SAMPLES FROM LOT#F759 WERE 100% VISUALLY INSPECTED, NO FINDINGS WERE OBSERVED. AS THE SAMPLE WAS NOT SENT BY THE CUSTOMER TO WEST IL, THE COMPLAINT SUBJECT COULD NOT BE FULLY INVESTIGATED. THEREFORE, ACCORDING TO AVAILABLE INFORMATION, THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    WEST PHARMA. SERVICES IL, LTD. (WEST IL) IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE WILL NOT BE 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.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE CUSTOMER, NOVO NORDISK, CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL), TO REPORT THAT DURING QUALITY CONTROL OF LOT F759, ONE (1) RETENTION SAMPLE OF THE VIAL ADAPTER 13 MM, WAS FOUND TO HAVE VISIBLE BLACK PARTICLES WITHIN THE SEAL OF THE PACKAGING AND ALSO ON THE INSIDE OF THE PACKAGED DEVICE. THE EVENT WAS DISCOVERED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096570 VIAL ADAPTER 13MM LONG W/25MIC FILTER-VF VIAL ADAPTER LHI WEST PHARMA. SERVICES IL, LTD F759 07290108240245

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown