BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE

    MDR report key: 13619860 · Received February 28, 2022

    Report

    Report Number
    1920898-2022-00129
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    February 15, 2022
    Report Date
    March 17, 2022
    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

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED SEVERAL IMAGES OF 4 SYRINGES WITH 0.3ML GRADUATION MARKINGS BUT NO OTHER IDENTIFICATION. THE SYRINGES HAD THEIR NEEDLE SHIELDS AND HUBS SEPARATE FROM THE BARRELS. THE HUBS HAVE BECOME LODGED INSIDE THE SHIELDS. THERE IS NO DAMAGE TO EITHER THE CONNECTORS AT THE DISTAL TIP OF THE BARREL OR THEIR RESPECTIVE NEEDLE HUBS. NO SIGNS OF USE AND NO OTHER DEFECTS FOUND. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1123341. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. BASED ON THE IMAGES RECEIVED, BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF NEEDLE HUB SEPARATION. CAPA#1630423 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGES EXPERIENCED THE CANNULA BREAKING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANIMAL CLINIC REPORTED NEEDLE/SHIELD SEPARATION FROM THE BARREL WHEN REMOVING THE SHIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGES EXPERIENCED THE CANNULA BREAKING OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ANIMAL CLINIC REPORTED NEEDLE/SHIELD SEPARATION FROM THE BARREL WHEN REMOVING THE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685796 BD ULTRA-FINE¿ 3/10ML INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1123341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown