BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 11531155 · Received March 19, 2021

    Report

    Report Number
    1920898-2021-00324
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 23, 2021
    Report Date
    April 23, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (6) LOOSE 3/10CC, 6MM SYRINGES. CUSTOMER STATES THAT SHE OBSERVED A LIQUID DROP COMES OUT OF THE CANNULA WHEN SHE PUSHED THE PLUNGER TO THE END. ALL RETURNED SYRINGES WERE EXAMINED AND ALL EXHIBITED A CLEAR DROPLET OF MATERIAL COMING OUT OF THE BARREL WHEN THE PLUNGER ROD WAS FULLY DEPRESSED. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY SILICONE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH#: 0083507 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 6 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED FOREIGN MATTER IN DEVICE CANNULA/NEEDLE/SYRINGE OR OTHER FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXCESSIVE SILICON OIL. A MOTHER OF T1DM PATIENT REPORTED THAT SHE OBSERVED A LIQUID DROP COMES OUT OF THE CANNULA WHEN SHE PUSHED THE PLUNGER TO THE END.

    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 6 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLES EXPERIENCED FOREIGN MATTER IN DEVICE CANNULA/NEEDLE/SYRINGE OR OTHER FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: EXCESSIVE SILICON OIL. A MOTHER OF T1DM PATIENT REPORTED THAT SHE OBSERVED A LIQUID DROP COMES OUT OF THE CANNULA WHEN SHE PUSHED THE PLUNGER TO THE END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428988 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 0083507 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1