BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE II INSULIN SYRINGE

    MDR report key: 11204129 · Received January 20, 2021

    Report

    Report Number
    1920898-2020-01806
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 30, 2020
    Report Date
    February 10, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 1/28/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (3) 1/2CC, 8MM, 30G SYRINGES IN AN OPEN POLY BAG FROM LOT # 0203552. CUSTOMER STATES THAT WHEN THE SHIELD WAS REMOVED, THE NEEDLE AND HUB BROKE OFF AND REMAINED IN THE SHIELD. ALL RETURNED SYRINGES WERE EXAMINED AND ONE SAMPLE EXHIBITED THE HUB-NEEDLE/SHIELD ASSEMBLY SEPARATED FROM THE BARREL. THE BARREL WAS ALSO EXAMINED AND EXHIBITED A DEFORMED BARREL TIP, WHICH PREVENTS THE HUB ASSEMBLY FROM SECURELY ATTACHING TO THE BARREL. NO DEFECTS WERE OBSERVED ON THE REMAINING SYRINGES. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0203552. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION [200901614] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. L2L MAINTENANCE DISPATCH #104909 DAMAGED BARREL TIP WAS GENERATED ON 02SEP2020 ON CR PRINTER. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HUB BROKE AND SEPARATED FROM THE BD ULTRA-FINE II¿ INSULIN SYRINGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED, WHEN SHE WENT TO REMOVE SHIELD, NEEDLE AND HUB BROKE OFF AND REMAINED INSIDE SHIELD."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE HUB BROKE AND SEPARATED FROM THE BD ULTRA-FINE II¿ INSULIN SYRINGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED, WHEN SHE WENT TO REMOVE SHIELD, NEEDLE AND HUB BROKE OFF AND REMAINED INSIDE SHIELD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99378 BD ULTRA-FINE II INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0203552

    Patients

    Seq Age Sex Outcome Treatment
    1