BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL ADAPTER 13MM FLL SIL - VF

    MDR report key: 17843568 · Received September 29, 2023

    Report

    Report Number
    3000223297-2023-00016
    Event Type
    Malfunction
    Date Received
    September 29, 2023
    Date of Event
    August 29, 2023
    Report Date
    September 29, 2023
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD
    Product Code
    LHI
    UDI-DI
    07290108240078
    PMA / PMN Number
    K001293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WEST PHARMA SERVICES IL (WEST IL) INVESTIGATED A COMPLAINT RECEIVED BY SHARP CLINICAL SERVICES LLC REGARDING A FOREIGN PARTICLE OBSERVED WITHIN A VIAL OF THE RECONSTITUTED SOLUTION WHICH COULD NOT BE DISSOLVED. THE PRODUCT WAS NOT RETURNED TO WEST IL FOR EVALUATION. HOWEVER, A PHOTOGRAPH WAS PROVIDED TO WEST IL WITH A VISIBLE PARTICLE AS REPORTED INSIDE OF THE VIAL. ACCORDING TO BATCH RECORDS REVIEW ON LOT NUMBER F547, IT WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE AND SHIPPED ACCORDING TO SPECIFICATIONS. THERE WERE NO RELATED NON-CONFORMANCES FOUND AND NO FINDINGS WERE OBSERVED. ADDITIONALLY, NO DEVIATIONS IN THE PRODUCTION PROCESS WERE FOUND. RETAINED SAMPLES FROM LOT #F547 WERE VISUALLY INSPECTED BY THE SUB-CONTRACTOR AND NO FINDINGS WERE OBSERVED. ACCORDING TO THE CUSTOMER, NO SAMPLES ARE AVAILABLE FOR INVESTIGATION. THE DESCRIBED PARTICLE COULD NOT PASS THROUGH THE SPIKE, SINCE THE DIMENSIONS OF THE PARTICLE REPORTED AS APPROXIMATELY 1-2MM, WHILE THE SPIKE TIP OF THE VIAL ADAPTER HAS 3 WINDOWS AND EACH WINDOW IS 0.5MM. AT THIS TIME, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    ON 01SEP2023, THE CUSTOMER, SHARP CLINICAL SERVICES LLC, CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL), TO REPORT THAT DURING RECONSTITUTION OF A MEDICATION (SOTATERCEPT 60MG OPEN LABEL PATIENT KITS) TO BE ADMINISTERED SUBCUTANEOUSLY, A GRAY PARTICLE WAS OBSERVED WITHIN THE SOLUTION THAT COULD NOT BE DISSOLVED. AS PER PHOTO PROVIDED, THE CUSTOMER COULD NOT PRECISELY PROVIDE THE DIMENSIONS OF THE PARTICLE, STATED "PERHAPS 1-2MM". THE VIAL ADAPTER, ALONG WITH THE MEDICATION AND DILUENT, WERE INSPECTED BEFORE PREPARATION STARTED AND THERE WERE NO ISSUES OBSERVED. A REPLACEMENT PRODUCT WAS PREPARED AND ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278566 VIAL ADAPTER 13MM FLL SIL - VF VIAL ADAPTER LHI WEST PHARMA. SERVICES IL, LTD F547 07290108240078

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown