BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G

    MDR report key: 8834178 · Received July 26, 2019

    Report

    Report Number
    9616656-2019-00672
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 4, 2019
    Report Date
    August 12, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    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 LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A UNDELIVERED INSULIN OCCURRED DURING USE WITH A BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "HI. MY SWEET MOM-IN-LAW IS HAVING A LOT OF TROUBLE WITH THE ABOVE NEEDLES. SHE SAYS THEY AREN'T INJECTING THE FULL AMOUNT OF HER RX 10 MG INSULIN. A DIABETIC NEIGHBOR WHO HAS TRIED TO HELP HER SAYS THE NEEDLES DON'T WORK AS WELL AS HERS. HER DOCTOR SAYS SHE IS GETTING ENOUGH EVEN IF SHE ISN'T GETTING THE FULL AMOUNT BECAUSE HER BLOOD SUGAR IS BEING MANAGED DECENTLY. HOWEVER MY M-I-L IS CONCERNED AS SHE SAYS ABOUT 4MG REMAINS UNINJECTED & SHE'S WASTING THE INSULIN. HAS THERE BEEN A RECALL? CAN SHE GET A REFUND? LOT# 8311935 EXP 2023-11-30 THANKS."

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ADDRESS IS UNKNOWN:  (B)(6) USA HAS BEEN USED AS A DEFAULT.  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 A UNDELIVERED INSULIN OCCURRED DURING USE WITH A BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "HI. MY SWEET MOM-IN-LAW IS HAVING A LOT OF TROUBLE WITH THE ABOVE NEEDLES. SHE SAYS THEY AREN'T INJECTING THE FULL AMOUNT OF HER RX 10 MG INSULIN. A DIABETIC NEIGHBOR WHO HAS TRIED TO HELP HER SAYS THE NEEDLES DON'T WORK AS WELL AS HERS. HER DOCTOR SAYS SHE IS GETTING ENOUGH EVEN IF SHE ISN'T GETTING THE FULL AMOUNT BECAUSE HER BLOOD SUGAR IS BEING MANAGED DECENTLY. HOWEVER MY M-I-L IS CONCERNED AS SHE SAYS ABOUT 4MG REMAINS UNINJECTED & SHE'S WASTING THE INSULIN. HAS THERE BEEN A RECALL? CAN SHE GET A REFUND? LOT# 8311935 EXP 2023-11-30. THANKS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623923 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM (5/32¿) 32G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8311935 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention