BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 15991861 · Received December 15, 2022

    Report

    Report Number
    1920898-2022-00879
    Event Type
    Malfunction
    Date Received
    December 15, 2022
    Date of Event
    November 24, 2022
    Report Date
    January 25, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (7) 3/10CC, 12.7MM, 29G SYRINGES IN AN OPEN POLY BAG FROM LOT # 2052357. CUSTOMER STATES THAT A CRACK ON THE BARREL WAS FOUND. ALL OF THE RETURNED SYRINGES WERE EXAMINED AND NO CRACKS WERE OBSERVED ON ANY OF THE SYRINGES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 2052357. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT 5 OF THE BD ULTRA-FINE¿ INSULIN SYRINGE WERE CRACKED ON BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT A DAMAGED BARREL. ACCORDING TO THE CUSTOMER'S REPORT, A CRACK ON THE BARREL WAS FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 OF THE BD ULTRA-FINE¿ INSULIN SYRINGE WERE CRACKED ON BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT A DAMAGED BARREL. ACCORDING TO THE CUSTOMER'S REPORT, A CRACK ON THE BARREL WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2503729 BD ULTRA-FINE¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2052357

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown