BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGS WITH THE BD ULTRA FINE¿NEEDLE

    MDR report key: 14842852 · Received June 28, 2022

    Report

    Report Number
    1920898-2022-00418
    Event Type
    Malfunction
    Date Received
    June 28, 2022
    Date of Event
    May 31, 2022
    Report Date
    July 28, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED A SINGLE 0.3ML SYRINGE. THERE WERE NO IMMEDIATELY VISIBLE DEFECTS. THE SYRINGE¿S FUNCTIONALITY WAS TESTED BY ATTEMPTING TO DRAW WATER INTO ITS BARREL. HOWEVER, NO WATER COULD BE DRAWN INTO THE SYRINGE. IT WAS ALSO NOTICED THAT THE PLUNGER ROD COULD NOT BE FULLY COMPRESSED AND WOULD BE FORCED BACK TO APPROXIMATELY THE 18 UNITS MARKER. A ROD WAS INSERTED INTO THE CANNULA OF THE SYRINGE AND AN OBSTRUCTION WAS FOUND TOWARD THE USER SIDE OF THE SYRINGE. THIS OBSTRUCTION COULD NOT BE REMOVED USING THE ROD. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8113511. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE FOUR (4) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE SYRINGE NOT DRAWING FLUID. NO ROOT CAUSE CAN BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGS WITH THE BD ULTRA FINE¿NEEDLE EXPERIENCING DIFFICULTY OPERATING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, NEEDLE WOULD NOT DRAW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGS WITH THE BD ULTRA FINE¿NEEDLE EXPERIENCING DIFFICULTY OPERATING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, NEEDLE WOULD NOT DRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043243 BD INSULIN SYRINGS WITH THE BD ULTRA FINE¿NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 8113511

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown