BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ ALLERGY SYRINGE TRAY

    MDR report key: 17605851 · Received August 23, 2023

    Report

    Report Number
    1920898-2023-00580
    Event Type
    Malfunction
    Date Received
    August 23, 2023
    Date of Event
    June 27, 2023
    Report Date
    April 24, 2025
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903059509
    PMA / PMN Number
    K992734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. 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

    BECTON DICKINSON AND COMPANY'S (BD) MEDICATION DELIVERY SOLUTIONS (MDS) BUSINESS UNIT WILL DISCONTINUE MALFUNCTION MDR REPORTING FOR CERTAIN DEVICE FAILURES THAT HAVE NOT CAUSED OR CONTRIBUTED TO DEATHS OR SERIOUS INJURIES IN THE PAST TWO YEARS, AND WHERE THE LIKELIHOOD OF A DEATH OR SERIOUS INJURY AS A RESULT OF THESE MALFUNCTIONS IS REMOTE. THIS DECISION FOLLOWS FDA GUIDELINES (MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ISSUED NOV 8, 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON MAR 3, 2025. FDA HAS REVIEWED AND RESPONDED TO BD¿S NOTIFICATION (REFERENCE FDA DOCUMENT # (B)(4)) ON MARCH 7, 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP) AS DIR 10000690801. THIS SUPPLEMENTAL MDR IS BEING FILED TO DOCUMENT THAT THE BELOW DEVICE FAILURE WILL NO LONGER BE CONSIDERED A REPORTABLE MALFUNCTION MDR FOR THE PRODUCT FAMILY BELOW: PRODUCT FAMILY: SAFETYGLIDE-ALLERGY. DEVICE FAILURE: MIXED PRODUCT/LOTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ ALLERGY SYRINGE TRAY THERE WAS A MIXTURE OF PRODUCTS IN THE PACKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER SAID THAT SHE IS OPENING THE BD 5950 1.0CC 27G X 1/2"SG SYRINGES BOXES, AND, IN EACH BOX, THERE ARE A FEW U100 INSULIN SYRINGES 1ML /CC INSULIN SYRINGES. RIGHT NOW, IT HAS HAPPENED IN AT LEAST EVERY POUCH THEY HAVE OPENED. THERE WAS NO DOCUMENTATION IN THE COMPLAINT REGARDING PATIENT IMPACT. SO FAR, THE NURSES REMOVED THE INSULIN SYRINGES AND USED THE 27GX1/2 SG SYRINGES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035564 BD SAFETYGLIDE¿ ALLERGY SYRINGE TRAY PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2221315 30382903059509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown