BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL ADAPTER 13MM LONG W/25MIC FILTER VF

    MDR report key: 19238381 · Received May 3, 2024

    Report

    Report Number
    3000223297-2024-00001
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    March 13, 2024
    Report Date
    August 9, 2024
    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, LTD. (WEST IL) IS CURRENTLY INVESTIGATING THIS COMPLAINT. PER THE CUSTOMER, 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.

    Additional Manufacturer Narrative · 0

    WEST PHARMA SERVICES IL (WEST IL) INVESTIGATED ON A COMPLAINT RECEIVED BY NOVO NORDISK REGARDING A LOOSE BLACK PARTICULATE MATTER OBSERVED WITHIN THE VIAL ADAPTER BLISTER PACK. ACCORDING TO BATCH RECORDS REVIEW, LOT NUMBER F768 WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES TESTED BEFORE RELEASE AND SHIPPED ACCORDING TO SPECIFICATIONS. THERE WERE NO NON-CONFORMANCES FOUND. NO OTHER COMPLAINTS WERE RECEIVED FROM LOT# F768. THE INCOMING INSPECTION OF THE BLISTER USED FOR LOT#F768 WERE REVIEWED, NO ISSUES WERE FOUND. 90 UNITS FROM RETAINED SAMPLES OF LOT# F768 WERE VISUALLY INSPECTED, NO ISSUES WERE NOTICED. THE SAMPLE WAS NOT RETURNED TO WEST IL FOR EVALUATION. HOWEVER, A PHOTO OF THE SAMPLE WAS PROVIDED. ACCORDING TO THE PHOTO, IT COULD NOT BE DETERMINED IF THE PARTICLE WAS LOCATED INSIDE THE BLISTER OR OUTSIDE OF THE BLISTER. ACCORDING TO AVAILABLE INFORMATION, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE CUSTOMER, NOVO NORDISK, CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL), TO REPORT THAT DURING THE IN PROCESS INSPECTION, PRIOR TO RELEASE TO THE MARKET OF THE VIAL ADAPTERS, A LOOSE BLACK PARTICULATE MATTER WAS OBSERVED WITHIN THE VIAL ADAPTER BLISTER PACK. THE AFFECTED LOT NUMBER INVOLVED IN THIS REPORTED EVENT IS F768.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030103 VIAL ADAPTER 13MM LONG W/25MIC FILTER VF VIAL ADAPTER LHI WEST PHARMA. SERVICES IL, LTD F768 07290108240245

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown