BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL ADAPTER

    MDR report key: 19793848 · Received July 22, 2024

    Report

    Report Number
    3000223297-2024-00003
    Event Type
    Malfunction
    Date Received
    July 22, 2024
    Date of Event
    March 15, 2024
    Report Date
    November 4, 2024
    Manufacturer
    WEST PHARMA SERVICES IL, LTD
    Product Code
    LHI
    PMA / PMN Number
    K001293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INCIDENT PERTAINED TO PRODUCT MARKETED IN JAPAN THAT IS SIMILAR TO PRODUCT MARKETED IN THE US. WEST PHARMA SERVICES IL, LTD. (WEST IL) INVESTIGATED A COMPLAINT RECEIVED BY ICST CORPORATION, WEST'S MARKET AUTHORIZATION HOLDER IN JAPAN, REGARDING A TEAR IN THE TYVEK OF THE VIAL ADAPTER 20MM, LOT# J002, WITHIN THE PRIMARY STERILE PACKAGE FOUND AT ICST'S CUSTOMER, JANSSEN. THE EFFECTED SAMPLE WAS NOT RETURNED TO WEST IL. THEREFORE, A SUPPLIER INVESTIGATION WAS PERFORMED. ACCORDING TO THE CONTRACT MANUFACTURER, LOT# J002 WAS MANUFACTURED WITH THE SAME TYVEK LOT WITHOUT REPLACING THE TYVEK ROLL. THE BATCH RECORDS WERE CHECKED AND RETAINED SAMPLES FROM LOT # J002 WERE VISUALLY INSPECTED BY THE CONTRACT MANUFACTURER, NO FINDINGS OR ISSUES WERE OBSERVED. LOT# J002 WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE, PACKED AND SHIPPED ACCORDING TO SPECIFICATIONS. THIS ISSUE IS CONSIDERED AS AN ISOLATED EVENT, AS IT WAS OBSERVED IN ONLY ONE UNIT OUT OF (B)(4) UNITS. THE INVESTIGATION FOUND THAT FINAL INSPECTION IS CONDUCTED BY THE CONTRACT MANUFACTURER BY OPENING CARTON BOXES AND INSPECTING THE PRODUCTS INSIDE THE BOX. IT WAS DETERMINED THAT THE CONTRACT MANUFACTURER'S FINAL INSPECTION RELEASE PROCEDURE WAS MISSING INSTRUCTIONS FOR THE METHOD OF OPENING THE BOXES FOR THE FINAL INSPECTION. IT IS POSSIBLE THE CONTRACT MANUFACTURER DAMAGED THE PRODUCT INSIDE AS THEY OPENED THE BOX FROM THE TOP AND NOT FROM THE SIDE USING A CUTTER KNIFE. THE CONTRACT MANUFACTURER INITIATED CORRECTIVE ACTIONS AND TRAINING FOR FINAL INSPECTION PRODUCT RELEASE TO ADD THE INSTRUCTION HOW TO OPEN THE CARTON BOX TO CHECK ITS CONTENT FOR FINAL RELEASE. THE DEVICE INVOLVED IN THE REPORTED EVENT IS NOT IN COMMERCIAL DISTRIBUTION UNDER A PREMARKET NOTIFICATION REGISTERED WITH FDA, AS THE DEVICE IN THE RECEIVED COMPLAINT IS DISTRIBUTED IN JAPAN ONLY. FOR THIS REASON, A US UDI FOR THIS CATALOG NUMBER IS NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    WEST PHARMA. SERVICES IL, LTD. (WEST IL) IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE HAS NOT YET BEEN RETURNED TO WEST IL FOR AN EVALUATION. HOWEVER, A PHOTOGRAPH WAS PROVIDED TO WEST IL WITH VISIBLE TEARS AS REPORTED ON THE TYVEK 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 25JUN2024, ICST CORPORATION, CONTACTED WEST PHARMA. SERVICES, IL LTD. (WEST IL), TO REPORT THAT DURING VISUAL INSPECTION, PRIOR TO USE, THE CUSTOMER, (B)(6) PHARMACEUTICALS, REPORTEDLY DETECTED TEARS IN THE TYVEK OF ONE VIAL ADAPTER, BREACHING STERILITY. ALTHOUGH THE TEARS IN THE TYVEK WERE CONFIRMED BY ICST TO HAVE BEEN CAUSED BY A CUTTER, ICST CONFIRMED THAT SHARP TOOLS ARE NOT UTILIZED DURING THE PACKAGING PROCESS. ADDITIONALLY, TWO VISUAL INSPECTIONS WERE PERFORMED AT ICST PRIOR TO RECEIPT OF THE SHIPMENT OF VIAL ADAPTERS AT (B)(6). HOWEVER, (B)(6) CONFIRMED THE PLASTIC BAG WITHIN THE SHIPPING BOX CONTAINING THE VIAL ADAPTERS DID NOT HAVE HOLES OR DAMAGE. THEREFORE, THE TEAR IN THE TYVEK HAD LIKELY OCCURRED PRIOR TO DELIVERY. ICST HAS IMPLEMENTED CORRECTIVE ACTIONS TO PREVENT FURTHER OCCURRENCES OF THIS ISSUE AND HAS CONDUCTED TRAINING FOR THEIR VISUAL INSPECTORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979928 VIAL ADAPTER VIAL ADAPTER 20MM FLL SIL TG - VF LHI WEST PHARMA SERVICES IL, LTD J002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown