BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG

    MDR report key: 11118646 · Received January 5, 2021

    Report

    Report Number
    1920898-2020-01797
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    December 7, 2020
    Report Date
    February 11, 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
    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 # 0083507 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS [200884826, 200884828] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG HAD FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT PET OWNER REPORTED HAVING ANOTHER SYRINGE WITH LIQUID INSIDE OF IT. VERBATIM: PET OWNER REPORTED HAVING ANOTHER SYRINGE WITH LIQUID INSIDE OF IT. STATED SHE ALSO RECEIVED HER MK BUT THE BOX LOOKED LIKE IT HAD BEEN CUT OPEN AT USPS. CONFIRMED SHE WILL BE SENDING THE MK BACK TOMORROW. REPORTED SAME ISSUE IN CS0036428. MK AND REPLACEMENT VOUCHER SENT OUT IN THAT FILE."

    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 HALF-UNIT 10BAG HAD FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT PET OWNER REPORTED HAVING ANOTHER SYRINGE WITH LIQUID INSIDE OF IT. VERBATIM: PET OWNER REPORTED HAVING ANOTHER SYRINGE WITH LIQUID INSIDE OF IT. STATED SHE ALSO RECEIVED HER MK BUT THE BOX LOOKED LIKE IT HAD BEEN CUT OPEN AT USPS. CONFIRMED SHE WILL BE SENDING THE MK BACK TOMORROW. REPORTED SAME ISSUE IN (B)(4). MK AND REPLACEMENT VOUCHER SENT OUT IN THAT FILE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15443 SYRINGE 0.3ML 31GA 6MM HALFUNIT 10BAG PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 324910 0083507 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1