BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD STERILE NEEDLE 0.23MM X 4MM 32G X 5/32"

    MDR report key: 10613446 · Received September 30, 2020

    Report

    Report Number
    MW5096998
    Event Type
    Malfunction
    Date Received
    September 30, 2020
    Date of Event
    September 29, 2020
    Report Date
    September 29, 2020
    Manufacturer
    BD
    Product Code
    NSC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME TO OBGYN CLINIC. GDM AT 22 WEEKS, SHE IS PRESCRIBED LANTUS 28 UNITS AM AND 14 UNITS HS AND LISPRO 14 UNITS BREAKFAST AND 12 UNITS DINNER. SHE BROUGHT BOTH HER LANTUS AND LISPRO PENS AS WELL AS BD PEN NEEDLES TO VISIT TODAY. REPORTS DIFFICULTY OVER THE PAST WEEK WITH LISPRO PEN ADMINISTRATION (FEELS PEN WAS STICKING AT NOT INJECTING). WITH PHARMACISTS AT VISIT, PEN WOULD NOT INJECTION; HOWEVER WHEN WE CHANGED TO A NEW PEN NEEDLES (DIFFERENT LOT) THE PEN WOULD WORK. THE SAME ISSUE WAS IDENTIFIED WHEN HER PRESCRIBED PEN NEEDLES (BD NANO 32G LOT 9353325 EXPIRE 01/31/2025) WERE USED ON HER LANTUS PEN. ISSUE APPEARS TO BE WITH HER PARTICULAR SUPPLY OF INSULIN PEN NEEDLES (CONTACTING HER (B)(6) FOR NEW SUPPLY AND DIFFERENT LOT NUMBER OF PEN NEEDLES) CANNOT RULE OUT PROBLEMS WITH LANTUS AND LISPRO PENS IT SELF (AS SHE SAID SHE WAS AFRAID SHE WASN'T GETTING ALL OF HER DOSE) AND PT ALSO REPORTS "RESISTANCE" WITH ADMINISTRATION OF INSULIN VIA PEN. ADVISED TO REPLACE LANTUS (LOT OF7100A EXPIRES 3/31/2023) AND LISPRO PENS (LOT 214632C, EXPIRES 02/2023).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1068825 BD STERILE NEEDLE 0.23MM X 4MM 32G X 5/32" NEEDLE, HYPODERMIC, SINGLE LUMEN NSC BD 9353325
    1068826 LANTUS SOLOSTAR PEN INJECTOR, PEN NSC UNK
    1068827 LISPRO PEN INJECTOR, PEN NSC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR