BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 9534214 · Received December 31, 2019

    Report

    Report Number
    1920898-2019-01486
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 12, 2019
    Report Date
    January 9, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (1) LOOSE 1/2CC, 8MM SYRINGE. CUSTOMER STATES THAT WHEN THE PLUNGER CAP WAS REMOVED THE PLUNGER ROD FELL OUT AND THE STOPPER WAS MISSING. THE RETURNED SYRINGE WAS EXAMINED AND EXHIBITED A MISSING STOPPER WHICH COULD CAUSE THE PLUNGER TO FALL OUT OF THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 8120882. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200756286] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. THERE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE PRODUCTION OF THIS BATCH THAT PERTAINED TO THIS DEFECT. ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE PLUNGER ROD FELL OUT OF BARREL WITH A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHEN PLUNGER CAP WAS REMOVED THE PLUNGER ROD FELL OUT.

    Additional Manufacturer Narrative · 1

    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 DURING USE THE PLUNGER ROD FELL OUT OF BARREL WITH A BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHEN PLUNGER CAP WAS REMOVED THE PLUNGER ROD FELL OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331639 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328468 8120882 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 Other