BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31G 5MM

    MDR report key: 10938074 · Received December 3, 2020

    Report

    Report Number
    9616656-2020-01214
    Event Type
    Malfunction
    Date Received
    December 3, 2020
    Date of Event
    November 9, 2020
    Report Date
    March 9, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 DHR REVIEW CANNOT BE CARRIED OUT FOR THIS LOT NUMBER AS THE PRODUCT HAS EXPIRED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NDL 31G 5MM EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NO EXPIRATION DATES ON PRODUCT BOXES. STATED HE HAS 3 BOXES OF PEN NEEDLES AND 2 BOXES OF INSULIN SYRINGES. STATED HE THINKS THEY ARE ABOUT 8 YEARS OLD. STATED HE USED SOME OF THE PEN NEEDLES, HE DID NOT KNOW THEY COULD BE EXPIRED. CONSUMER COULD NOT LOCATE A TRADEMARK OR MANUFACTURE DATE ON PRODUCT BOXES. ADVISED CONSUMER PRODUCTS ARE TESTED FOR 5 YEARS AND THESE BOXES COULD BE EXPIRED. LOT # 7313351 . LOT # 8162554. LOT # 8310783. CAT # 320882 - SAME FOR ALL 3 BOXES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN: (B)(6) HAS BEEN USED AS A DEFAULT.  THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7313351, MEDICAL DEVICE EXPIRATION DATE: N/A, DEVICE MANUFACTURE DATE: 2008-01-03. MEDICAL DEVICE LOT #: 8162554, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2008-08-28. MEDICAL DEVICE LOT #: 8310783, MEDICAL DEVICE EXPIRATION DATE: NA, DEVICE MANUFACTURE DATE: 2009-01-07. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEN NDL 31G 5MM EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED NO EXPIRATION DATES ON PRODUCT BOXES. STATED HE HAS 3 BOXES OF PEN NEEDLES AND 2 BOXES OF INSULIN SYRINGES. STATED HE THINKS THEY ARE ABOUT 8 YEARS OLD. STATED HE USED SOME OF THE PEN NEEDLES, HE DID NOT KNOW THEY COULD BE EXPIRED. CONSUMER COULD NOT LOCATE A TRADEMARK OR MANUFACTURE DATE ON PRODUCT BOXES. ADVISED CONSUMER PRODUCTS ARE TESTED FOR 5 YEARS AND THESE BOXES COULD BE EXPIRED. LOT # 7313351, LOT # 8162554, LOT # 8310783. CAT # 320882 - SAME FOR ALL 3 BOXES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1402564 PEN NDL 31G 5MM PEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1