BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 29G 12.7MM 10BAG 500 EU

    MDR report key: 12037570 · Received June 21, 2021

    Report

    Report Number
    1920898-2021-00677
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 25, 2021
    Report Date
    July 2, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9231025. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 SYRINGE 0.5ML 29G 12.7MM 10BAG 500 EU HAD FOREIGN MATTER (2) AND LEAKAGE (1) DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "I HAVE FOUND SO FAR TWO SYRINGES WHICH APPEAR TO HAVE SOME FLUID IN THE BARREL STRAIGHT OUT THE PACKET. I FIRST NOTICED WHEN I PUSHED THE AIR OUT OF THE SYRINGE LIKE NORMAL BEFORE I CAN DRAW UP MY MEDICATION AND THE FLUID LEAKED FROM THE NEEDLE. TODAY I COULD FOUND ONE WITH A CLEARLY VISIBLE AMOUNT OF FLUID IN BEFORE I EVEN REMOVED THE CAP.¿

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 SYRINGE 0.5ML 29G 12.7MM 10BAG 500 EU HAD FOREIGN MATTER (2) AND LEAKAGE (1) DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "I HAVE FOUND SO FAR TWO SYRINGES WHICH APPEAR TO HAVE SOME FLUID IN THE BARREL STRAIGHT OUT THE PACKET. I FIRST NOTICED WHEN I PUSHED THE AIR OUT OF THE SYRINGE LIKE NORMAL BEFORE I CAN DRAW UP MY MEDICATION AND THE FLUID LEAKED FROM THE NEEDLE. TODAY I COULD FOUND ONE WITH A CLEARLY VISIBLE AMOUNT OF FLUID IN BEFORE I EVEN REMOVED THE CAP.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933609 SYRINGE 0.5ML 29G 12.7MM 10BAG 500 EU PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 9231025

    Patients

    Seq Age Sex Outcome Treatment
    1