BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LO-DOSE U-100 INSULIN SYRINGE WITH BD MICRO-FINE IV NEEDLE

    MDR report key: 9587169 · Received January 14, 2020

    Report

    Report Number
    1920898-2019-01542
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 27, 2019
    Report Date
    January 22, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903294610
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THIS COMPLAINT WILL BE CANCELLED. THIS WAS OPENED UNDER THE WRONG BUSINESS. THIS IS A DC PRODUCT. A COMPLAINT HAS BEEN OPENED IN THE DC BUSINESS, PR# 1398777, MFR REPORT # 1920898-2020-00020 THAT HAS ALREADY BEEN REPORTED FOR MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LO-DOSE¿ U-100 INSULIN SYRINGE WITH BD MICRO-FINE¿ IV NEEDLE PLUNGER ROD WAS DIFFICULT TO MOVE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329461, BATCH NO: 9211307. IT WAS REPORTED THAT THE PLUNGER ROD WAS DIFFICULT TO MOVE. EVENT DESCRIPTION PER EMAIL STATES: I HAVE AN ISSUE WITH SOME SYRINGES WE RECENTLY GOT IN. WE RECENTLY GOT THESE SYRINGES. WE HAVE USED THE SIZE AND BRAND FREQUENTLY AND HAVE NEVER HAD THIS PROBLEM. THE PLUNGER WORKS REALLY HARD ON A HIGH PERCENTAGE OF THEM SUCH THAT IT IS REALLY NEARLY IMPOSSIBLE TO USE TO INJECT BECAUSE YOU HAVE TO PUSH WITH SUCH A FORCE WILL INJECTING INTO VERY YOUNG MICE. WE NORMALLY MOVE THE PLUNGER IN AND OUT A FEW TIMES BEFORE WE DRAW UP THE SOLUTION TOO SO THAT IS NOT THE ISSUE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD LO-DOSE¿ U-100 INSULIN SYRINGE WITH BD MICRO-FINE¿ IV NEEDLE PLUNGER ROD WAS DIFFICULT TO MOVE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329461 BATCH NO: 9211307. IT WAS REPORTED THAT THE PLUNGER ROD WAS DIFFICULT TO MOVE. EVENT DESCRIPTION PER EMAIL STATES: I HAVE AN ISSUE WITH SOME SYRINGES WE RECENTLY GOT IN. WE RECENTLY GOT THESE SYRINGES. WE HAVE USED THE SIZE AND BRAND FREQUENTLY AND HAVE NEVER HAD THIS PROBLEM. THE PLUNGER WORKS REALLY HARD ON A HIGH PERCENTAGE OF THEM SUCH THAT IT IS REALLY NEARLY IMPOSSIBLE TO USE TO INJECT BECAUSE YOU HAVE TO PUSH WITH SUCH A FORCE WILL INJECTING INTO VERY YOUNG MICE. WE NORMALLY MOVE THE PLUNGER IN AND OUT A FEW TIMES BEFORE WE DRAW UP THE SOLUTION TOO SO THAT IS NOT THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52614 BD LO-DOSE U-100 INSULIN SYRINGE WITH BD MICRO-FINE IV NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 329461 9211307 30382903294610

    Patients

    Seq Age Sex Outcome Treatment
    1 Other