BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIXJECT 13MM FTH RIBS 30G

    MDR report key: 17373410 · Received July 21, 2023

    Report

    Report Number
    3000223297-2023-00012
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    June 27, 2023
    Report Date
    October 23, 2023
    Manufacturer
    WEST PHARMA. SERVICES IL, LTD
    Product Code
    LHI
    UDI-DI
    07290108241044
    PMA / PMN Number
    K001293
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WEST PHARMA SERVICES IL (WEST IL) INVESTIGATED A COMPLAINT RECEIVED BY BAYER AG, REGARDING FIVE UNITS OF THE MIXJECT REPORTED TO BE MISSING THE TYVEK SEALING FOIL ON EACH UNIT. ALL FIVE SAMPLES WERE RETURNED TO WEST IL FOR EVALUATION ON (B)(6) 2023 AND WERE CONFIRMED MISSING THE TYVEK SEAL. ADDITIONALLY, THERE WAS NO OBSERVED SEALING MARKS ON THE BLISTER OF ALL FIVE RETURNED UNITS. RETAINED SAMPLES OF LOT#F575 WERE VISUALLY INSPECTED AND NO ISSUES WERE NOTICED; ALL THE (B)(4) PRODUCTS WERE SEALED. ACCORDING TO BATCH RECORDS REVIEW ON LOT NUMBER F575 NO ISSUES WERE NOTICED. HOWEVER, IT IS LIKELY THAT DURING THE MANUFACTURING PROCESS, THE FIVE UNSEALED AND REJECTED PRODUCTS, MAY HAVE BEEN UNINTENTIONALLY MANUALLY PLACED INTO A SEALING BAG BY THE SUB-CONTRACTOR AS FINISHED PRODUCT. ACCORDING TO THE SUB-CONTRACTOR'S INVESTIGATION REPORT, TRAINING FOR RELEVANT EMPLOYEES WAS PERFORMED TO RAISE AWARENESS ON THEIR PROCEDURE TO PREVENT FUTURE OCCURRENCE OF THIS EVENT. THE SUB-CONTRACTOR HAS SINCE UPDATED THEIR PROCEDURE TO REFLECT COLLECTION OF REJECTED PRODUCTS IN A DESIGNATED BAG AND AREA. ADDITIONALLY, A SUPERVISOR IS OVERSEEING THE PRODUCTION AREA FOR BETTER QUALITY CONTROL. THEREFORE, INSUFFICIENT PROCEDURE FOR COLLECTING REJECTED PRODUCTS DURING PRODUCTION, IS THE MOST PROBABLE ROOT CAUSE FOR THIS REPORTED ISSUE.

    Additional Manufacturer Narrative · 0

    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 WHICH SHOWED THE MISSING TYVEK SEALING FOIL. 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, (B)(6), CONTACTED WEST PHARMA SERVICES, IL LTD (WEST IL) ON (B)(6) 2023 TO REPORT THAT DURING IN-PROCESS INSPECTION AND PRIOR TO USE OF THE MIXJECT 13MM FTH RIBS 30G, LOT F575, FIVE UNITS WERE DISCOVERED TO BE MISSING THE TYVEK SEALING FOIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1873647 MIXJECT 13MM FTH RIBS 30G MIXJECT 13MM FTH RIBS 30G LHI WEST PHARMA. SERVICES IL, LTD 9070115 F575 07290108241044

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown