BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALGREENS THIN INSULIN SYRINGES

    MDR report key: 15559841 · Received October 7, 2022

    Report

    Report Number
    1920898-2022-00693
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 15, 2022
    Report Date
    October 13, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    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# 1172392. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING WALGREENS THIN INSULIN SYRINGES THE CAP COULD NOT BE REMOVED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE NEEDLE SHIELD IS DIFFICULT TO REMOVE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING WALGREENS THIN INSULIN SYRINGES THE CAP COULD NOT BE REMOVED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE NEEDLE SHIELD IS DIFFICULT TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1419053 WALGREENS THIN INSULIN SYRINGES PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1172392

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown