BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 13865138 · Received March 23, 2022

    Report

    Report Number
    1920898-2022-00183
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    March 8, 2022
    Report Date
    April 20, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    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 EVALUTION? YES. D9: RETURNED TO MANUFACTURER ON: 28-MAR-2022. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED 9 SYRINGES IN AN OPEN POLYBAG FOR 0.3ML, 31 GAUGE, 8MM SYRINGES FROM LOT 9112698. EACH OF THE SYRINGES RETURNED FEATURES SOME FORM OF DAMAGE TO THE NECK OF THE PLUNGER IMMEDIATELY BEFORE THE THUMBPRESS ON THE PROXIMAL END OF THE SYRINGE. THIS DAMAGE RANGES FROM SOME POTENTIAL WEAR AND BENDING TO THE PLUNGER TO THE ENTIRE THUMBPRESS BEING BROKEN OFF. THE MINIMALLY DAMAGED SYRINGES WERE FUNCTIONALLY TESTED BY DRAWING WATER. THESE SYRINGES WERE ALL CAPABLE OF DRAWING FLUIDS, BUT CANNOT BE USED TO DRAW/DELIVER INSULIN AS INTENDED BASED ON THE DAMAGE AROUND THE THUMBPRESSES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #9112698. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE SAMPLES RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE SYRINGES BEING DIFFICULT TO OPERATE BASED ON THE DAMAGE AROUND THE THUMBPRESSES. ROOT CAUSE: MAINTENANCE DISPATCH (L2L) WAS REVIEWED, AND A DISPATCH WAS INITIATED FOR PREP DAIL INHIBIT GATE JAMS. AT THE TRANSPORT RAIL FEEDING INTO THE INDEX DIAL / TUBE, THE SYRINGES WERE GOING IN AT A ANGLE CAUSING DAMAGE TO ONE END OF THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEVERAL BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE THUMB PRESSES WERE BROKEN AND WOULD NOT DRAW UP INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FOUND 3 BOXES TO HAVE BROKEN THUMB PRESSES ON THE PLUNGER RODS. CONSUMER REPORTED TRIED TO USE THE SYRINGE WITH BROKEN THUMB PRESS AND FOUND THEY WOULD NOT DRAW UP INSULIN. JUST AIR."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEVERAL BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE THUMB PRESSES WERE BROKEN AND WOULD NOT DRAW UP INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FOUND 3 BOXES TO HAVE BROKEN THUMB PRESSES ON THE PLUNGER RODS. CONSUMER REPORTED TRIED TO USE THE SYRINGE WITH BROKEN THUMB PRESS AND FOUND THEY WOULD NOT DRAW UP INSULIN. JUST AIR"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767975 BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328438 9112698 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown