BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 9522090 · Received December 26, 2019

    Report

    Report Number
    1920898-2019-01473
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    April 9, 2019
    Report Date
    January 7, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908440035
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED TWO (2) LOOSE 31GX8MM BD INSULIN SYRINGES. CONSUMER STATED SYRINGES WERE OF DIFFERENT MEASUREMENTS AND THEY AFFECTED HER SON'S GLUCOSE. BOTH RETURNED SYRINGES WERE EXAMINED, THEN TESTED USING A 0.3ML SYRINGE PLUG GAUGE: IT WAS OBSERVED THAT ONE OF THE SYRINGES FELL OUT OF SPECIFICATION OF THE PLUG GAUGE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9161989. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. A VISUAL EVALUATION OF THE SYRINGES USING A PLUG GAUGE (GAUGE# 10372) DETERMINED THE SCALE IS IN THE CORRECT LOCATION FOR (1) OF THE SYRINGES. VOLUMETRIC TESTING WAS PERFORMED ON THOSE (2) SYRINGES AND WERE IN THE ACCEPTABLE LIMITS. THESE MEET THE REQUIREMENTS OF ISO 8537. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MISALIGNED SCALE WAS FOUND DURING USE WITH A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "HELLO, I WANT TO BRING THIS TO YOUR ATTENTION. IT'S BEEN (B)(4) YEARS THAT MY SON HAS BEEN USING THE BD SYRINGES AND EACH BOX HAD DIFFERENT MEASUREMENTS. IN ALL CASES THE MEASUREMENTS WERE DIFFERENT. ONE IS A SYRINGE OF (B)(4) UNIT AND THE OTHER THE SAME (B)(4) UNIT SHOWS (B)(4) UNITS. I HAVE BEEN FIGHTING WITH BD ABOUT THIS. IT AFFECTED MY SON GLUCOSE FOR 5 YEARS. THOSE ERRORS CAN CAUSE HYPOGLYCEMIA AND HYPERGLYCEMIA WHICH CAN LEAD TO DEATH CAUSES."

    Additional Manufacturer Narrative · 1

    FDA NOTIFIED: THE INITIAL REPORTER ALSO NOTIFIED THE FDA VIA MEDWATCH # MW5091141. 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 MISALIGNED SCALE WAS FOUND DURING USE WITH A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE . THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "HELLO, I WANT TO BRING THIS TO YOUR ATTENTION. IT'S BEEN 5 YEARS THAT MY SON HAS BEEN USING THE BD SYRINGES AND EACH BOX HAD DIFFERENT MEASUREMENTS. IN ALL CASES THE MEASUREMENTS WERE DIFFERENT. ONE IS A SYRINGE OF 1 UNIT AND THE OTHER THE SAME 1 UNIT SHOWS 1.5 UNITS. I HAVE BEEN FIGHTING WITH BD ABOUT THIS. IT AFFECTED MY SON GLUCOSE FOR 5 YEARS. THOSE ERRORS CAN CAUSE HYPOGLYCEMIA AND HYPERGLYCEMIA WHICH CAN LEAD TO DEATH CAUSES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316771 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9161989 00382908440035

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Other