BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 6MM 90 BX 450 MO

    MDR report key: 10838204 · Received November 13, 2020

    Report

    Report Number
    1920898-2020-01563
    Event Type
    Malfunction
    Date Received
    November 13, 2020
    Date of Event
    October 20, 2020
    Report Date
    January 26, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249084
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9070693. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE FIVE (5) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 1.0ML 6MM 90 BX 450 MO WAS UNABLE TO CONTAIN MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLES ARE DULL. ALSO REPORTED SYRINGE BARREL WAS CRACKED AND LEAKED INSULIN. VERBATIM: VOICEMAIL: CONSUMER LEFT VOICEMAIL STATING THAT THE NEEDLES ARE DULL AND THE SYRINGE IS BROKEN. (B)(6) 2020: I RETURNED CONSUMER'S CALL, HE STATED THAT THE SYRINGE HAS A CRACK IN THE SIDE OF THE BARREL THAT CAUSES THE INSULIN TO LEAK OUT. CONSUMER ALSO REPORTED THAT THE NEEDLES ARE DULL. CONSUMER DOES NOT RE-USE."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE 1.0ML 6MM 90 BX 450 MO WAS UNABLE TO CONTAIN MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLES ARE DULL. ALSO REPORTED SYRINGE BARREL WAS CRACKED AND LEAKED INSULIN. VERBATIM: VOICEMAIL: CONSUMER LEFT VOICEMAIL STATING THAT THE NEEDLES ARE DULL AND THE SYRINGE IS BROKEN. 10-20-20: I RETURNED CONSUMER'S CALL, HE STATED THAT THE SYRINGE HAS A CRACK IN THE SIDE OF THE BARREL THAT CAUSES THE INSULIN TO LEAK OUT. CONSUMER ALSO REPORTED THAT THE NEEDLES ARE DULL. CONSUMER DOES NOT RE-USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300494 SYRINGE 1.0ML 6MM 90 BX 450 MO PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324908 9070693 00382903249084

    Patients

    Seq Age Sex Outcome Treatment
    1