BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE

    MDR report key: 11121822 · Received January 6, 2021

    Report

    Report Number
    1920898-2021-00006
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 8, 2020
    Report Date
    January 29, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10/D11: CONCOMITANT MEDICAL PRODUCTS: DEVICE AVAILABLE FOR EVAL?: YES. D10/D11: CONCOMITANT MEDICAL PRODUCTS: RETURNED TO MANUFACTURER ON: 12/28/2020. H.6. INVESTIGATION: CUSTOMER RETURNED (2) LOOSE 3/10CC SYRINGES. CUSTOMER STATES THAT THE SHIELDS ARE HARD TO REMOVE. CUSTOMER STATES THAT THE NEEDLE WAS MISSING AFTER THE SHIELD WAS REMOVED. BOTH RETURNED SYRINGES WERE EXAMINED AND BOTH EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9112704. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS EXCEPT AS NOTED BELOW. THERE WERE THREE (3) NOTIFICATIONS [200821671, 200821662, 200821922] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. ROOT CAUSE: ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. CAPA# (B)(4) WAS INITIATED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, SHIELDS ARE HARD TO REMOVE. STATED, NEEDLE HUB SEPARATED AFTER PULLING ON SHIELD ONCE, THE NEEDLE WAS MISSING COMPLETELY AFTER REMOVING SHIELD. LOT: 9112704. CATALOG: 328440. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, SHIELDS ARE HARD TO REMOVE STATED, NEEDLE HUB SEPARATED AFTER PULLING ON SHIELD ONCE, THE NEEDLE WAS MISSING COMPLETELY AFTER REMOVING SHIELD LOT: 9112704, CATALOG: 328440, DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20302 BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9112704

    Patients

    Seq Age Sex Outcome Treatment
    1