BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31G 8MM 90 COUNT MAIL ORDER ONLY

    MDR report key: 11276560 · Received February 3, 2021

    Report

    Report Number
    9616656-2021-00108
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    January 12, 2021
    Report Date
    March 9, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BOXES OF PEN NDL 31G 8MM 90 COUNT MAIL ORDER ONLY HAD MISSING LABEL INFORMATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT 5 BOXES OF PEN NEEDLES WERE MISSING EXPIRATION DATES. VERBATIM: CONSUMER STATED HE HAS 5 BOXES OF PEN NEEDLES WITH NO EXPIRATION DATES ON THEM. STATED ALL THE BOXES ARE THE SAME 8MM 31 G PEN NEEDLES. TRADEMARK DATE OF 2011 ON ALL PRODUCT BOXES. BOXES HAVE NOT BEEN USED. LOT # 7151838 - 2 BOXES. LOT # 6355769 - 2 BOXES. LOT # 7236631".

    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 #: 7151838 MEDICAL DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE: (B)(6) 2017. MEDICAL DEVICE LOT #: 6355769 MEDICAL DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE: (B)(6) 2016. MEDICAL DEVICE LOT #: 7236631 MEDICAL DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE: (B)(6) 2017. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 BOXES OF PEN NDL 31G 8MM 90 COUNT MAIL ORDER ONLY HAD MISSING LABEL INFORMATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT 5 BOXES OF PEN NEEDLES WERE MISSING EXPIRATION DATES. VERBATIM: CONSUMER STATED HE HAS 5 BOXES OF PEN NEEDLES WITH NO EXPIRATION DATES ON THEM. STATED ALL THE BOXES ARE THE SAME 8MM 31 G PEN NEEDLES. TRADEMARK DATE OF 2011 ON ALL PRODUCT BOXES. BOXES HAVE NOT BEEN USED. LOT # 7151838 - 2 BOXES, LOT # 6355769 - 2 BOXES, LOT # 7236631."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170273 PEN NDL 31G 8MM 90 COUNT MAIL ORDER ONLY HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1