BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIX2VIAL¿ 20/20MM

    MDR report key: 23878150 · Received December 23, 2025

    Report

    Report Number
    3000223297-2025-00010
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Date of Event
    November 21, 2025
    Report Date
    April 15, 2026
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD.
    Product Code
    LHI
    UDI-DI
    07290108240672
    PMA / PMN Number
    K031861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WHILE IT WAS REQUESTED THAT THE DEVICE BE RETURNED TO THE MANUFACTURER TO AID IN THE INVESTIGATION, IT WAS NOT RECEIVED. BATCH RECORD REVIEW: A BATCH RECORD REVIEW OF LOT J966 CONFIRMED THAT THE AFFECTED LOT WAS MANUFACTURED ACCORDING TO RELEVANT PROCEDURES, TESTED PRIOR TO RELEASE, AND SHIPPED ACCORDING TO SPECIFICATIONS. NO NON-CONFORMANCES RELATED TO THIS CLAIM WERE IDENTIFIED DURING THE BATCH RECORD REVIEW. ALL QC INSPECTIONS WERE CONDUCTED ACCORDING TO PROCEDURES DURING PRODUCTION, AND NO DEVIATIONS WERE IDENTIFIED. COMPLAINT DATABASE REVIEW: A REVIEW OF THE COMPLAINTS DATABASE FOR THE PERIOD FROM DECEMBER 2022 UNTIL DECEMBER 2025 SHOWED NO JUSTIFIED COMPLAINTS FOR LOT J966 DURING THE PERIOD IN QUESTION. ONE JUSTIFIED COMPLAINT WAS IDENTIFIED FOR THIS CATALOG NUMBER IN 2023; HOWEVER NO JUSTIFIED COMPLAINTS HAVE BEEN RECEIVED FOR THE REPORTED ISSUE. RETAINED SAMPLES REVIEW: RETAINED SAMPLES FROM LOT J966 WERE 200% VISUALLY INSPECTED BY THE SUB-CONTRACTOR AS PART OF THE IN-PROCESS TESTING, AND NO FINDINGS WERE OBSERVED. SUB-CONTRACTOR INVESTIGATION: A SUPPLIER COMPLAINT (B)(4) WAS SENT TO THE SUB-CONTRACTOR. ACCORDING TO THE INVESTIGATION, LOT J966 WAS PRODUCED ON MACHINE MP404 BETWEEN 09-15 OCTOBER 2024. PRODUCTION WAS CARRIED OUT ON A SEMI-AUTOMATIC MACHINE, WHICH WAS OPERATED BY TWO EMPLOYEES SIMULTANEOUSLY, WITH ONE ASSEMBLING PRODUCTS AND FEEDING THEM INTO THE MACHINE, WHILE THE SECOND PLACED THE BLISTER ON EACH ASSEMBLED PRODUCT AFTER COMPLETION OF THE ASSEMBLY PROCESS. BOTH EMPLOYEES ARE TRAINED AND CERTIFIED ACCORDING TO THE CLEANROOM BEHAVIOUR PROCEDURE, INCLUDING PROPER GLOVE USAGE AND TEAR IDENTIFICATION. NO REAL-TIME REPORT OF A GLOVE TEAR WAS DOCUMENTED IN THE BATCH RECORD. HOWEVER, AT THE TIME OF THE INCIDENT THERE WAS NO REQUIREMENT TO RECORD A DEVIATION OF THIS NATURE IN THE BATCH RECORD. ADDITIONALLY, NO PRODUCTION STOP OR PRODUCT ISOLATION WAS PERFORMED DURING THE PRODUCTION OF LOT J966. NO MECHANICAL FAILURES WERE FOUND IN MP-404 THAT COULD CAUSE GLOVE TEARING. THE PRODUCTION PROCESS INCLUDES MANUAL STEPS, WHICH MAKES IT MORE SUSCEPTIBLE TO FOREIGN MATERIAL CONTAMINATION THAN THAT OF A FULLY AUTOMATED PROCESS. THEREFORE, BASED ON THE SUB-CONTRACTOR INVESTIGATION AND AN ANALYSIS OF THE PROCESS, IT IS POSSIBLE THAT ONE OF THE EMPLOYEE'S GLOVES TORE DURING THE PRODUCTION PROCESS, WITH A PIECE OF IT ENTERING THE PRODUCT WITHOUT THE EMPLOYEE NOTICING. ROOT CAUSE: THE ROOT CAUSE WAS DETERMINED TO BE A RESULT OF A COMBINATION OF: - MANUAL WORK STEPS WHICH INCREASE THE RISK OF FOREIGN MATERIAL INGRESS. - FAILURE TO DETECT GLOVE TEARING IN REAL TIME. - INSUFFICIENT PROCEDURES REGARDING THE REQUIRED ACTIONS IN THE CASE OF GLOVE TEARS. CORRECTIVE ACTIONS TAKEN: IMMEDIATE STEPS WERE TAKEN TO UPDATE AND STRENGTHEN THE SUBCONTRACTOR'S CLEAN ROOM BEHAVIOUR PROCEDURE (3BGI02 REV. 02), INCLUDING THE FOLLOWING PROVISIONS IN RELATION TO GLOVE TEARS: - IMMEDIATE PRODUCTION STOP IN CASE OF GLOVE TEAR. - IMMEDIATE REPORTING TO QUALITY FOR THE OPENING OF A NON-CONFORMITY REPORT. - QUARANTINE OF ALL PRODUCTS MANUFACTURED PRIOR TO THE GLOVE TEAR. - SEARCH FOR GLOVE REMNANTS UNTIL FULL VERIFICATION OF EVENT CLOSURE. - FOLLOW PROCEDURE 3BQS03 REV 25.0 "NON-CONFORMING PRODUCT CONTROL". - GLOVE REPLACEMENT MUST NOT OCCUR NEAR COMPONENTS, RAW MATERIALS, OR PRODUCTS; REPLACEMENT ONLY IN AREAS AWAY FROM PRODUCT. PROVIDE EMPLOYEE TRAINING. - CONDUCT TRAINING FOR ALL EMPLOYEES ON UPDATED PROCEDURE 3BGI02 REV 25.0, EMPHASIZING GLOVE TEAR DETECTION AND PROPER REPLACEMENT FREQUENCY. EFFECTIVENESS CHECK: THE EFFECTIVENESS CHECK OF THE CORRECTIVE ACTIONS INCLUDES: - BI-WEEKLY OBSERVATIONS OF WORKERS DURING PRODUCTION, WITH A FOCUS ON STOPPING WORK AND IMMEDIATELY REPORTING GLOVE TEARS TO QUALITY. - GLOVE REPLACEMENT EVERY TWO HOURS IN ACCORDANCE WITH PROCEDURE BGI02. - RECORDING OF ANY DEVIATION OR IMPROPER CONDUCT. - EVALUATION OF EFFECTIVENESS UNTIL MAY-2026.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS CURRENTLY UNDER INVESTIGATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    THE CUSTOMER, PFIZER, CONTACTED THE DEVICE MANUFACTURER ON 01DEC2025 TO REPORT THAT DURING PRODUCTION, FOREIGN MATERIAL WAS OBSERVED BY A PACKAGING TECHNICIAN INSIDE A SEALED, STERILE MIX2VIAL DEVICE. THE VISUAL INSPECTION OF THE FOREIGN MATERIAL APPEARED TO BE A PIECE OF A WHITE GLOVE. THE SEALED DEVICE WAS SENT TO THE CUSTOMER'S IN-HOUSE LAB FOR TESTING WHICH CONFIRMED THAT THE FOREIGN MATERIAL WAS PART OF A NITRILE GLOVE. AS 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
    321689 MIX2VIAL¿ 20/20MM MIX2VIAL¿ 20/20MM LHI WEST PHARMA. SERVICES IL, LTD. J966 07290108240672

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown