BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS

    MDR report key: 11220043 · Received January 23, 2021

    Report

    Report Number
    1920898-2021-00098
    Event Type
    Malfunction
    Date Received
    January 23, 2021
    Date of Event
    January 4, 2021
    Report Date
    April 14, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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# 0252891. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:328466 BATCH NO: 0252891, UNKNOWN. IT WAS REPORTED THAT ABOUT 15 SYRINGES HAD CROOKED OR SLANTED LINE SON THE BARREL. ALSO, SOME OF THE LINES WERE SMEARED AND DUE TO THIS THE PET'S BLOOD SUGAR WAS HIGH OR LOW. THIS PR CAPTURES THE OCCURRENCE FOR THE UNKNOWN PRODUCT REPORTED BY THE CONSUMER. VERBATIM: PET OWNER STATED ABOUT 15 SYRINGES HAD CROOKED OR SLANTED LINES ON THE BARREL. STATED SOME OF THE LINES ON THE BARREL WERE ALSO SMEARED. STATED DUE TO THIS, HER PETS BLOOD SUGAR WOULD RUN HIGHER OR LOWER. PET OWNER STATED SHE REPORTED THIS TO HER PHARMACY AND THE PHARMACIST STATED THEY HAD ANOTHER CONSUMER REPORT THE SAME ISSUE WITH ANOTHER PRODUCT BOX.

    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 SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:328466 BATCH NO: 0252891, UNKNOWN. IT WAS REPORTED THAT ABOUT 15 SYRINGES HAD CROOKED OR SLANTED LINE SON THE BARREL. ALSO, SOME OF THE LINES WERE SMEARED AND DUE TO THIS THE PET'S BLOOD SUGAR WAS HIGH OR LOW. THIS PR CAPTURES THE OCCURRENCE FOR THE UNKNOWN PRODUCT REPORTED BY THE CONSUMER. VERBATIM: PET OWNER STATED ABOUT 15 SYRINGES HAD CROOKED OR SLANTED LINES ON THE BARREL. STATED SOME OF THE LINES ON THE BARREL WERE ALSO SMEARED. STATED DUE TO THIS, HER PETS BLOOD SUGAR WOULD RUN HIGHER OR LOWER. PET OWNER STATED SHE REPORTED THIS TO HER PHARMACY AND THE PHARMACIST STATED THEY HAD ANOTHER CONSUMER REPORT THE SAME ISSUE WITH ANOTHER PRODUCT BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116249 SYRINGE 0.5ML 30GA 1/2IN UF 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0252891

    Patients

    Seq Age Sex Outcome Treatment
    1