BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32X4 LA

    MDR report key: 11574266 · Received March 26, 2021

    Report

    Report Number
    9616656-2021-00325
    Event Type
    Malfunction
    Date Received
    March 26, 2021
    Date of Event
    March 2, 2021
    Report Date
    April 28, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS COMPLAINT CAPTURES LOT NUMBERS 3143128 AND 4311148. THE OTHER LOT NUMBERS MENTIONED IN THE ENTRY DESCRIPTION (LOT NUMBERS 2340015, 5006500, AND 4100307) AND THE LOT NUMBER OF THE SAMPLE SHOWN IN THE PHOTO (LOT # 3190471) ARE CAPTURED AND WILL BE INVESTIGATED UNDER COMPLAINT 2524722. NO SAMPLES (INCLUDING PHOTOS) FROM LOT # 4311148 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NEEDLE 32X4 LA WAS MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320479 BATCH NO: 3143128, 4311148 IT WAS REPORTED THAT THE CUSTOMER IS CHECKING FOR THE EXPIRATION DATE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 3143128 MEDICAL DEVICE EXPIRATION DATE: 2018-04-30 DEVICE MANUFACTURE DATE: (B)(6) 2013. MEDICAL DEVICE LOT #: 4311148 MEDICAL DEVICE EXPIRATION DATE: 2019-10-31 DEVICE MANUFACTURE DATE: (B)(6) 2014. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NEEDLE 32X4 LA WAS MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320479, BATCH NO: 3143128, 4311148. IT WAS REPORTED THAT THE CUSTOMER IS CHECKING FOR THE EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474313 PEN NEEDLE 32X4 LA PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1