BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE + INSULIN SYRINGE WITH NEEDLE

    MDR report key: 11798542 · Received May 10, 2021

    Report

    Report Number
    1920898-2021-00537
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 12, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0090585. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE¿ + INSULIN SYRINGE WITH NEEDLE HAD A LOOSE PLASTIC PARTICLE ON THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM LUXEMBOURGISH TO ENGLISH: "LOOSE PLASTIC PARTICLE IN FRONT OF THE PLUNGER."

    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 THE BD MICRO-FINE¿ + INSULIN SYRINGE WITH NEEDLE HAD A LOOSE PLASTIC PARTICLE ON THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM LUXEMBOURGISH TO ENGLISH: "LOOSE PLASTIC PARTICLE IN FRONT OF THE PLUNGER"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696300 BD MICRO-FINE + INSULIN SYRINGE WITH NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0090585

    Patients

    Seq Age Sex Outcome Treatment
    1