BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NDL 31GA 8MM

    MDR report key: 12457022 · Received September 10, 2021

    Report

    Report Number
    9616656-2021-01133
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    August 12, 2021
    Report Date
    September 29, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201099
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD PEN NDL 31GA 8MM HAD A LABEL INFORMATION ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE SPOUSE OF THE CONSUMER STATED FINDING BOXES OF UNOPENED SYRINGES FROM HER DECEASED HUSBAND WITHOUT AN EXPIRATION DATE.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS : LOT # : 6061834¿DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE : 03/01/2016. LOT # : 7193690¿DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE : 07/12/2017. LOT # : 7096678 ¿ DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE : 04/06/2017. LOT # : 5112137 ¿ DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE :06/09/2015. 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 4 BD PEN NDL 31GA 8MM HAD A LABEL INFORMATION ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE SPOUSE OF THE CONSUMER STATED FINDING BOXES OF UNOPENED SYRINGES FROM HER DECEASED HUSBAND WITHOUT AN EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350587 BD PEN NDL 31GA 8MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320109 SEE H.10 00382903201099

    Patients

    Seq Age Sex Outcome Treatment
    1