BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG

    MDR report key: 10977904 · Received December 9, 2020

    Report

    Report Number
    1920898-2020-01688
    Event Type
    Malfunction
    Date Received
    December 9, 2020
    Date of Event
    November 3, 2020
    Report Date
    April 2, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 # 0041287 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE HUB SEPARATED AND NEEDLE WAS MISSING. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: PET OWNER CALLED STATING A FEW WEEKS AGO SHE REMOVED THE NEEDLE CAP ON ONE SYRINGE AND THE NEEDLE WAS TUCKED INTO THE ORANGE CAP. STATED ONE SYRINGE ALSO HAD NO NEEDLE AT ALL."

    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 0.3ML 31GA 6MM HALFUNIT 10BAG SEPARATED FROM THE HUB DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE HUB SEPARATED AND NEEDLE WAS MISSING. EVENT DESCRIPTION PER EMAIL STATES: PET OWNER CALLED STATING A FEW WEEKS AGO SHE REMOVED THE NEEDLE CAP ON ONE SYRINGE AND THE NEEDLE WAS TUCKED INTO THE ORANGE CAP. STATED ONE SYRINGE ALSO HAD NO NEEDLE AT ALL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441543 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 0041287 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1