BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 10963572 · Received December 7, 2020

    Report

    Report Number
    9616656-2020-01233
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    September 29, 2020
    Report Date
    March 4, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K933545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY 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 A PEN NDL 32G 4MM 100BX 1200 USA WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE INSULIN WAS NOT INJECTING AND THAT RESISTANCE WAS MET DURING ADMINISTRATION. EVENT DESCRIPTION PER ATTACHED MEDWATCH REPORT STATES: PATIENT CAME TO OBGYN CLINIC. GDM AT 22 WEEKS, SHE IS PRESCRIBED LANTUS 28 UNITS AM AND 14 UNITS HS AND LISOPRO 14 UNITS BREAKFAST AND 12 UNITS DINNER. SHE BROUGHT BOTH HER LANTUS AND LISOPRO PENS AS WELL AS BD PEN NEEDLES TO VISIT TODAY. REPORTS DIFFICULTY OVER THE PAST WEEK WITH LISOPRO 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 PEN NEEDLES (CONTACTING HER (B)(6) FOR NEW SUPPLY AND DIFFERENT LOT NUMBER OF PEN NEEDLES) CANNOT RULE OUT PROBLEMS WITH THE LANTUS AND LISOPRO 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 LISOPRO PENS (LOT 214632C, EXPIRES 02/2023).".

    Additional Manufacturer Narrative · 1

    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 A PEN NDL 32G 4MM 100BX 1200 USA WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE INSULIN WAS NOT INJECTING AND THAT RESISTANCE WAS MET DURING ADMINISTRATION. EVENT DESCRIPTION PER ATTACHED MEDWATCH REPORT STATES: PATIENT CAME TO OBGYN CLINIC. GDM AT 22 WEEKS, SHE IS PRESCRIBED LANTUS 28 UNITS AM AND 14 UNITS HS AND LISOPRO 14 UNITS BREAKFAST AND 12 UNITS DINNER. SHE BROUGHT BOTH HER LANTUS AND LISOPRO PENS AS WELL AS BD PEN NEEDLES TO VISIT TODAY. REPORTS DIFFICULTY OVER THE PAST WEEK WITH LISOPRO 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 PEN NEEDLES (CONTACTING HER (B)(6) FOR NEW SUPPLY AND DIFFERENT LOT NUMBER OF PEN NEEDLES) CANNOT RULE OUT PROBLEMS WITH THE LANTUS AND LISOPRO 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 LISOPRO PENS (LOT 214632C, EXPIRES 02/2023)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428242 PEN NDL 32G 4MM 100BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 9353325 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1