BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 6MM 90 BX 450 MO

    MDR report key: 10838169 · Received November 13, 2020

    Report

    Report Number
    1920898-2020-01565
    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

    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 FAILED 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. VOICEMAIL: CONSUMER LEFT VOICEMAIL STATING THAT THE NEEDLES ARE DULL AND THE SYRINGE IS BROKEN. ON (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. 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 FAILED 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. ON 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
    1299998 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