BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 29GA SHIELD BULK

    MDR report key: 8506043 · Received April 11, 2019

    Report

    Report Number
    9616656-2019-00340
    Event Type
    Malfunction
    Date Received
    April 11, 2019
    Date of Event
    March 26, 2019
    Report Date
    May 3, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED PHOTOS OF THE COC AND A SHELF CARTON OF BD PEN NEEDLES FROM LOT # 8003809. CUSTOMER STATES THAT THEY FOUND A DISCREPANCY IN THE DATE OF MANUFACTURING REPORTED ON THE COC AND ON THE CARTON. THE ATTACHED PHOTOS WERE EXAMINED AND THE COC LISTS A MANUFACTURING DATE OF JAN2018 WHILE THE SHELF CARTON LISTS A MANUFACTURING DATE OF JAN2019. AS PER DIABETES CARE TEAM, THE DOM ON THE CERTIFICATE OF CONFORMANCE IS FOR THE BULK PEN NEEDLES THAT WERE PRODUCED BY DUN LAOGHAIRE AND USED TO BE PACKAGED INTO THE 3 COUNT BOX. THE DOM WAS 01 JAN 2018 AND THEREFORE THE EXPIRY DATE WOULD BE DEC 2022 (5 YEARS MINUS 1 MONTH). ONCE PACKED OUT INTO THE 3 COUNT CONFIGURATION (FINAL PACKAGING) AT BEMIS A NEW DOM MANUFACTURER IS CREATED FOR THE FINISHED GOOD, HOWEVER THE EXPIRY DATE REMAINS THE SAME AS THE BULK. BEMIS CONFIRMED THAT IT HAS ALWAYS BEEN THE WAY THIS IS DONE. GIVEN THIS INFORMATION, THIS ISSUE CANNOT BE CONFIRMED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MANUFACTURING DATE PRINTED ON THE PEN NDL 29GA SHIELD BULK CARTON WAS 2019-01, WHILE THE MANUFACTURING DATE PRINTED ON THE CERTIFICATE OF CONFORMANCE WAS 2018-01-01. THE DEFECT WAS FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING INCOMING CONTROL OF THE ABOVE MENTIONED BATCH, WE FOUND A DISCREPANCY IN THE DATE OF MANUFACTURING REPORTED ON THE COC AND ON THE CARTON. THE DATE OF MANUFACTURING REPORTED ON CARTON BOX: 2019/01. ONE YEAR DIFFERENCE COMPARED TO THE DATE OF MANUFACTURING REPORTED ON COC."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MANUFACTURING DATE PRINTED ON THE PEN NDL 29GA SHIELD BULK CARTON WAS 2019-01, WHILE THE MANUFACTURING DATE PRINTED ON THE CERTIFICATE OF CONFORMANCE WAS 2018-01-01. THE DEFECT WAS FOUND BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING INCOMING CONTROL OF THE ABOVE MENTIONED BATCH, WE FOUND A DISCREPANCY IN THE DATE OF MANUFACTURING REPORTED ON THE COC AND ON THE CARTON. THE DATE OF MANUFACTURING REPORTED ON CARTON BOX: 2019/01. ONE YEAR DIFFERENCE COMPARED TO THE DATE OF MANUFACTURING REPORTED ON COC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297753 PEN NDL 29GA SHIELD BULK HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8003809

    Patients

    Seq Age Sex Outcome Treatment
    1 Other