BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE

    MDR report key: 15769404 · Received November 10, 2022

    Report

    Report Number
    1920898-2022-00781
    Event Type
    Malfunction
    Date Received
    November 10, 2022
    Date of Event
    October 13, 2022
    Report Date
    October 17, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER FACILITY NAME: (B)(6). INVESTIGATION SUMMARY: SINCE NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED FOR THE SYRINGE 1.0ML 30GA 8MM BLS 500CAS AP, PRODUCT CODE #326702, LOT #1103828, WITH THE REPORTED ISSUE OF FOREIGN MATTER, THE COMPLAINT COULD NOT BE CONFIRMED, AND THE ROOT CAUSE IS UNDETERMINED. 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# 1103828. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) /SITUATION ANALYSIS (SA) ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED FOREIGN MATTER ON DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORTED SEEING "CLEAR HARD SUBSTANCE" ON NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482532 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1103828

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown