BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIAL ADAPTER

    MDR report key: 20560222 · Received October 29, 2024

    Report

    Report Number
    3000223297-2024-00005
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    September 20, 2024
    Report Date
    January 15, 2025
    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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF BATCH RECORDS FOR LOT#J906 REVEALED NO NON-CONFORMANCE. ALL QC INSPECTIONS WERE CONDUCTED ACCORDING TO PROCEDURES, NO OTHER ISSUES WERE IDENTIFIED. ACCORDING TO OUR RECORDS, LOT#J906 WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED BEFORE RELEASE, PACKED AND SHIPPED ACCORDING TO SPECIFICATIONS. COMPLAINTS DATABASE WAS REVIEWED; NO JUSTIFIED COMPLAINTS WERE IDENTIFIED FOR THIS LOT. NO COMPLAINTS WERE RECEIVED RELATED TO LOT# J906. RETAINED SAMPLES FROM LOT#J906 WERE 100% VISUALLY INSPECTED BY THE CONTRACT MANUFACTURER - NO FINDINGS WERE OBSERVED. THE RETURNED SAMPLE WAS RECEIVED ON 09-OCT-2024 AND WERE INSPECTED, THE TYVEK WAS DETECTED WITH HOLE. THE REPORTED ISSUE WAS VERIFIED. A SUPPLIER COMPLAINT WAS SENT TO THE CONTRACT MANUFACTURER TO INVESTIGATE THIS ISSUE. ACCORDING TO THE CONTRACT MANUFACTURER'S PRELIMINARY INVESTIGATION, THE BATCH RECORDS WERE CHECKED, NO ISSUES WERE NOTICED. THIS ISSUE WAS REPORTED WITH ONE PRODUCT OUT OF 180,100 MANUFACTURED PRODUCTS THEREFORE CONSIDERED AN ISOLATED EVENT AND THE ROOT CAUSE OF THE REPORTED COMPLAINT COULD NOT BE PRECISELY DETERMINED. A SIMILAR PRODUCT WAS TESTED, AND IT APPEARS THAT THE DEFECT ONLY OCCURRED AFTER APPLYING LOCAL PRESSURE IN THE SPIKE AREA. DURING THE ENTIRE PRODUCTION PROCESS OF THIS ITEM, NO POINT WAS IDENTIFIED WHERE LOCAL PRESSURE COULD BE APPLIED DIRECTLY ABOVE THE SPIKE.

    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 A VISIBLE SMALL PERFORATION 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

    THE CUSTOMER, PFIZER CONTACTED THE DEVICE MANUFACTURER ON 30SEP2024 TO REPORT THAT DURING IN-PROCESS INSPECTION, PRIOR TO CO-PACKAGING OF THE VIAL ADAPTER DEVICE WITH MEDICINAL PRODUCT, LOT J906, THE BLISTER OF ONE (1) VIAL ADAPTER OF 315 WAS FOUND TO BE PERFORATED AT THE TYVEK. THIS DEFICIENCY WAS FOUND PRIOR TO CO-PACKAGING OF THE DEVICE WITH THE DRUG PRODUCT AND PRIOR USE. THE DEVICE HAD NOT YET ENTERED INTO THE DISTRIBUTION STAGE TO THE END USER (I.E. BEING PUT INTO SERVICE), THERE WAS NO HEALTH IMPACT TO THE END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301757 VIAL ADAPTER VIAL ADAPTER 13MM FLL SIL VF LHI WEST PHARMA. SERVICES IL, LTD J906 07290108240078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown