BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM

    MDR report key: 11882428 · Received May 26, 2021

    Report

    Report Number
    1920898-2021-00598
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    April 28, 2021
    Report Date
    May 27, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    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 DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0232707. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD SYRINGE 0.5ML 31GA 8MM HAD FOREIGN MATTER ON THE DEVICE CANNULA / IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : MATERIAL NO. 328468 . BATCH NO. 0232707. THE CONSUMER REPORTED LIQUID IN THE SYRINGE AND ALSO THAT THERE WAS AN AIR BUBBLE INSIDE OF THE LIQUID. THE CONSUMER STATED THAT THIS WAS A NEW SYRINGE AND DOES NOT RE-USE. DATE OF EVENT: UNKNOWN SAMPLES: AVAILABLE - SENDING MAIL KIT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS PENDING BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 BD SYRINGE 0.5ML 31GA 8MM HAD FOREIGN MATTER ON THE DEVICE CANNULA / IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : MATERIAL NO. 328468 BATCH NO. 0232707. THE CONSUMER REPORTED LIQUID IN THE SYRINGE AND ALSO THAT THERE WAS AN AIR BUBBLE INSIDE OF THE LIQUID. THE CONSUMER STATED THAT THIS WAS A NEW SYRINGE AND DOES NOT RE-USE. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781022 SYRINGE 0.5ML 31GA 8MM PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0232707

    Patients

    Seq Age Sex Outcome Treatment
    1