BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17552458 · Received August 15, 2023

    Report

    Report Number
    1920898-2023-00560
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    July 17, 2023
    Report Date
    April 24, 2025
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    MEG
    UDI-DI
    00382903059508
    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

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2304576 D.4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2027 H.4. DEVICE MANUFACTURE DATE: 31-OCT-2022 D.4. MEDICAL DEVICE LOT #: 2251991 D.4. MEDICAL DEVICE EXPIRATION DATE: 30-SEPT-2027 H.4. DEVICE MANUFACTURE DATE: 08-SEPT-2022. H3. 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

    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: SCALE MARKING ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE EXPERIENCED SCALE MARKING ISSUES. WITH LOT NUMBERS 2304576 AND 2251991. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME WITHOUT NUMBERING SO FAR 15 OF THEM.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791810 BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE PISTON SYRINGE MEG BD MEDICAL - DIABETES CARE SEE H.10 00382903059508

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown