BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 13541449 · Received February 16, 2022

    Report

    Report Number
    1920898-2022-00106
    Event Type
    Malfunction
    Date Received
    February 16, 2022
    Date of Event
    February 2, 2022
    Report Date
    March 12, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED SEVERAL IMAGES OF A SINGLE SYRINGE AND A POLYBAG FOR 1ML, 29 GAUGE, 12.7MM SYRINGES FROM LOT 1242583. THE SYRINGE NEEDLE FEATURES A BEAD OF CLEAR, STRINGY MATERIAL PARTWAY DOWN THE LENGTH OF THE NEEDLE. IN ADDITION, THERE IS A SIMILAR UNKNOWN MATERIAL INSIDE THE BARREL OF THE SYRINGE ITSELF. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1242583. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE IMAGES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF FOREIGN MATTER ON THE NEEDLE. THE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES HAD FOREIGN MATTER ON THE DEVICE CANNULA AND IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED PARTICLES AND DEBRIS INSIDE THE SYRINGE AT THE SPACE ON THE TOP OF THE SYRINGE, AND FURTHERMORE THAT AFTER THE CAP HAS BEEN REMOVED, ONE CAN CLEARLY SEE BITS OF PLASTIC ON THE NEEDLE ITSELF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES HAD FOREIGN MATTER ON THE DEVICE CANNULA AND IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED PARTICLES AND DEBRIS INSIDE THE SYRINGE AT THE SPACE ON THE TOP OF THE SYRINGE, AND FURTHERMORE THAT AFTER THE CAP HAS BEEN REMOVED, ONE CAN CLEARLY SEE BITS OF PLASTIC ON THE NEEDLE ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537812 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1200429

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown