BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 10789345 · Received November 4, 2020

    Report

    Report Number
    9616656-2020-01102
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Date of Event
    October 14, 2020
    Report Date
    January 20, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FRN
    UDI-DI
    10885403928659
    PMA / PMN Number
    K933545
    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 THESE PACKAGED LOTS 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 PEN NDL 32G 4MM 100BX 1200 HAD MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS NO EXPIRATION DATE ON BOXES. VERBATIM: FROM PHONE CALL ON (B)(6)2020 15:09:31: PARENT CALLED IN FROM EMAIL HE RECEIVED FROM BD REP. PARENT STATED HE DOES NOT SEE AN EXPIRATION DATE ON ANY OF THE PRODUCT BOXES. STATED ALL 4 PRODUCT BOXES HAVE THE MANUFACTURE DATE OF 2014. INFORMED CONSUMER THAT BD TESTS THE PRODUCTS FOR 5 YEARS. ALSO PROVIDED CAT # 320122 FOR ALL PRODUCT BOXES AND STATED THE BOXES WERE NOT OPENED. LG. EMAIL RECEIVED¿2020-10-14 16:40:25 HI, I HAVE SOME BOXES OF BD ULTRA-FINE PEN NEEDLES THAT ONLY HAVE LOT NUMBERS ON THEM. I WANT TO MAKE SURE I KNOW WHEN THEY EXPIRE BEFORE I LET MY DAUGHTER USE THEM. "

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7312912, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: 2017-11-08. MEDICAL DEVICE LOT #: 7299684, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: 2017-10-26. MEDICAL DEVICE LOT #: 8030726, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: 2018-03-23. MEDICAL DEVICE LOT #: 8047615, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: 2018-04-17. 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 PEN NDL 32G 4MM 100BX 1200 HAD MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE IS NO EXPIRATION DATE ON BOXES. VERBATIM: FROM PHONE CALL ON 2020-10-15 15:09:31: PARENT CALLED IN FROM EMAIL HE RECEIVED FROM BD REP. PARENT STATED HE DOES NOT SEE AN EXPIRATION DATE ON ANY OF THE PRODUCT BOXES. STATED ALL 4 PRODUCT BOXES HAVE THE MANUFACTURE DATE OF 2014. INFORMED CONSUMER THAT BD TESTS THE PRODUCTS FOR 5 YEARS. ALSO PROVIDED CAT # 320122 FOR ALL PRODUCT BOXES AND STATED THE BOXES WERE NOT OPENED. EMAIL RECEIVED 2020-10-14 16:40:25: HI, I HAVE SOME BOXES OF BD ULTRA-FINE PEN NEEDLES THAT ONLY HAVE LOT NUMBERS ON THEM. I WANT TO MAKE SURE I KNOW WHEN THEY EXPIRE BEFORE I LET MY DAUGHTER USE THEM. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254185 PEN NDL 32G 4MM 100BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FRN BECTON DICKINSON AND CO. 2865 SEE H.10. 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1