BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD MICRO-FINE IV NEEDLE

    MDR report key: 12147604 · Received July 9, 2021

    Report

    Report Number
    1920898-2021-00740
    Event Type
    Malfunction
    Date Received
    July 9, 2021
    Date of Event
    June 11, 2021
    Report Date
    July 23, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903294610
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED TWO IMAGES OF TWO 0.5ML SYRINGES. EACH OF THESE SYRINGES FEATURES A BEAD OF A CLEAR MATERIAL MIDWAY ALONG THE LENGTH OF THE NEEDLE. THIS MATERIAL MAY BE EXCESSIVE ADHESIVE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0132264. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WAS ONE (1) NOTIFICATION NOTED FOR EXCESSIVE SILICONE. BASED ON THE IMAGES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF FOREIGN MATTER AT THE CANNULA. THERE WERE NO NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE TIME OF THIS BATCH THAT PERTAINED TO THE DEFECT. NO ROOT CAUSE CAN BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD INSULIN SYRINGES WITH THE BD MICRO-FINE¿ IV NEEDLE HAD EXCESS SILICONE IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I DON'T THINK THAT IT'S WATER, I BELIEVE IT TO BE EXCESS SILICONE OIL TO LUBRICATE THE SYRINGE."

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 BD INSULIN SYRINGES WITH THE BD MICRO-FINE¿ IV NEEDLE HAD EXCESS SILICONE IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I DON'T THINK THAT IT'S WATER, I BELIEVE IT TO BE EXCESS SILICONE OIL TO LUBRICATE THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043017 BD INSULIN SYRINGE WITH THE BD MICRO-FINE IV NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 329461 0132264 30382903294610

    Patients

    Seq Age Sex Outcome Treatment
    1