BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL ADAPTER

    MDR report key: 20561885 · Received October 29, 2024

    Report

    Report Number
    3000223297-2024-00007
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    September 24, 2024
    Report Date
    March 31, 2025
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD
    Product Code
    LHI
    UDI-DI
    07290108240184
    PMA / PMN Number
    K001293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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 PRIMARY PACKAGING COMPROMISE OF THE DEVICE. UPON COMPLETION OF THE INVESTIGATION AND IF ADDITIONAL INFORMATION IS PROVIDED FROM THE MANUFACTURER'S CUSTOMER A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A REVIEW OF BATCH RECORDS FOR LOT#H275 REVEALED NO NON-CONFORMANCE. ALL QC INSPECTIONS WERE CONDUCTED ACCORDING TO PROCEDURES, NO OTHER ISSUES WERE IDENTIFIED. ACCORDING TO THE MANUFACTURER'S RECORDS, LOT#H275 WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE, PACKED AND SHIPPED ACCORDING TO SPECIFICATIONS. COMPLAINTS DATABASE OF THE LAST THREE YEARS WAS REVIEWED; THERE WERE NO COMPLAINTS IDENTIFIED FOR THIS LOT. 15 COMPLAINTS WERE RECEIVED FOR CATALOG# 8072107, NONE OF THE COMPLAINTS WERE DETERMINED AS JUSTIFIED. RETAINED SAMPLES FROM LOT#H275 WERE VISUALLY INSPECTED, NO FINDINGS WERE OBSERVED. THE SAMPLE WAS RETURNED TO THE MANUFACTURER AND THE ISSUE WAS VERIFIED. ACCORDING TO THE SUB-CONTRACTORS' INVESTIGATION, SPECIAL INSTRUCTIONS WERE WRITTEN AS IMMEDIATE CORRECTION TO AVOID THIS ISSUE FROM RECURRING AND RE-TRAINING OF RELEVANT PROCEDURES WERE PERFORMED. THE ROOT CAUSE OF THE UNSEALED PRODUCTS IS DUE TO INSUFFICIENT EXECUTION OF PROCEDURE AFTER THE EMERGENCY BUTTON WAS PRESSED OR THE SAFETY CURTAIN WAS ACTIVATED. A CAPA WAS OPENED BY THE CONTRACT MANUFACTURER TO ADDRESS THE ISSUE INCLUDING HOLDING AWARENESS TRAINING AND TRAINING ON THE SPECIAL INSTRUCTION. THE CAPA IS CLOSED WITH CORRECTIVE ACTIONS AND EFFECTIVE CHECK WAS VERIFIED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE CUSTOMER, SANOFI PHARMACEUTICAL CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL), TO REPORT THAT TWO (2) VIAL ADAPTER 20MM W/5MIC FILTER, LOT#: H275, WERE REJECTED DUE TO OPEN UNSEALED BLISTERS OF THE PRIMARY PACKAGING. WHEN THE END USER OPENED THE KIT, OF THE CO-PACKAGED VIAL ADAPTER, LOT#: H275, KITTED WITH A MEDICINAL PRODUCT, THE TYVEK ON THE DEVICE CAME OFF THE VIAL ADAPTER. 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
    979250 VIAL ADAPTER VIAL ADAPTER 20MM FLL SIL WITH 5UM FILTER - VF LHI WEST PHARMA. SERVICES IL, LTD H275 07290108240184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown