BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALGREENS SUPER THIN II SYRINGE SHORT NEEDLE

    MDR report key: 16547520 · Received March 15, 2023

    Report

    Report Number
    1920898-2023-00132
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 23, 2023
    Report Date
    April 6, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES 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# 1221876. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WALGREENS SUPER THIN II SYRINGE SHORT NEEDLE HAD SCALE MARKING ISSUES WHERE THE "0" BEGAN AT A DIFFERENT PLACE ON THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PET OWNER REPORTED A DISCREPENCY WITH SCALE MARKINGS ON BARREL. STATED, THE "0" MARKING STARTS AT DIFFENT PLACES ON THE BARREL STATED, WHEN SHE DRAWS INSULIN FOR HER PET, SHE IS CONCERNED WITH OVER DOSING OR UNDER DOSING."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WALGREENS SUPER THIN II SYRINGE SHORT NEEDLE HAD SCALE MARKING ISSUES WHERE THE "0" BEGAN AT A DIFFERENT PLACE ON THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PET OWNER REPORTED A DISCREPANCY WITH SCALE MARKINGS ON BARREL. STATED, THE "0" MARKING STARTS AT DIFFERENT PLACES ON THE BARREL STATED, WHEN SHE DRAWS INSULIN FOR HER PET, SHE IS CONCERNED WITH OVER DOSING OR UNDER DOSING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915288 WALGREENS SUPER THIN II SYRINGE SHORT NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1221876

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown