BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALGREENS SUPER THIN II SYRINGE SHORT NEEDLE

    MDR report key: 16547448 · Received March 15, 2023

    Report

    Report Number
    1920898-2023-00133
    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

    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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WALGREENS SUPER THIN II SYRINGE SHORT NEEDLE HAD "EXTRA INSULIN" INSIDE THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STATED, SHE IS ALSO NOTICING SOME EXTRA INSULIN IN THE HUB THAT SHE THINKS IS GOING INSIDE HER PET."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WALGREENS SUPER THIN II SYRINGE SHORT NEEDLE HAD "EXTRA INSULIN" INSIDE THE HUB DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STATED, SHE IS ALSO NOTICING SOME EXTRA INSULIN IN THE HUB THAT SHE THINKS IS GOING INSIDE HER PET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768960 WALGREENS SUPER THIN II SYRINGE SHORT NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1221876

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown