BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 16664239 · Received April 3, 2023

    Report

    Report Number
    1920898-2023-00184
    Event Type
    Malfunction
    Date Received
    April 3, 2023
    Date of Event
    March 13, 2023
    Report Date
    March 13, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    UDI-DI
    00382903059508
    PMA / PMN Number
    K992734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2221315. MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2027. DEVICE MANUFACTURE DATE: 09-AUG-2022. MEDICAL DEVICE LOT #: 2101496. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2027. DEVICE MANUFACTURE DATE: 11-APR-2022. 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

    (B)(4) ¿ FOLLOW UP MDR FOR DEVICE EVALUATION. FOUR PHOTOS WERE RECEIVED WITH THE CUSTOMER'S COMPLAINT OF MIXED PRODUCT IN PACKAGING. THE COMPLAINT WAS VERIFIED BUT WITHOUT FURTHER INFORMATION THE ROOT CAUSE REMAINS UNKNOWN. THE PRODUCTION HISTORY WAS ANALYZED AND THERE WERE NO ISSUES FOUND DURING QUALITY INSPECTIONS THAT WOULD LEAD TO THIS ISSUE. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. YOUR ASSISTANCE IN THIS MATTER HAS BEEN HELPFUL IN TREND IDENTIFICATION AND SUPPORTING OUR COMMITMENT TO CONTINUOUS QUALITY IMPROVEMENT. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE EACH FROM LOTS 2221315 AND 2101496 HAD ISSUES WITH INSULIN SYRINGES BEING MIXED IN WITH THE ALLERGY SYRINGES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE CONTINUE TO HAVE THE SAME ISSUES WITH SYRINGES FROM THE SAME LOTS. REPORTED ISSUE: HAS BEEN RECEIVING TRAYS THAT SHOULD CONTAIN ALLERGY SYRINGES BUT WILL OCCASIONALLY FIND 1-3 INSULIN SYRINGES MIXED IN THE TRAY."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529242 BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE PISTON SYRINGE MEG BD MEDICAL - DIABETES CARE SEE H10 00382903059508

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown