BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE PRECISIONGLIDE 16X1-1/2IN

    MDR report key: 23418552 · Received October 29, 2025

    Report

    Report Number
    3003916417-2025-00242
    Event Type
    Malfunction
    Date Received
    October 29, 2025
    Date of Event
    June 9, 2025
    Report Date
    November 14, 2025
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE UNITS IN UNIT. THE ANALYSIS OF THE LOT HISTORY (DHR) WAS CARRIED OUT, AS WELL AS THE VERIFICATION OF QUALITY NOTIFICATIONS. BASED ON THE PHOTO SENT BY THE CUSTOMER, IT WAS POSSIBLE TO CONFIRM THE REPORTED INCIDENT. MAINTENANCE ORDER NO. (B)(4) WAS IDENTIFIED, RELATED TO THE LINE RESPONSIBLE FOR THE PACKAGING PROCESS. ACCORDING TO THE RECORDS IN THIS ORDER, THE ROOT CAUSE WAS ATTRIBUTED TO A FAILURE IN THE NEEDLE FEEDER AND ALSO IN THE VISION SYSTEM RESPONSIBLE FOR INSPECTING THE PACKAGING. ADJUSTMENTS WERE MADE TO THE VISION SYSTEM TO PROPERLY CONFIGURE THE NEWLY INSTALLED EQUIPMENT. THE PARTS ARE INSPECTED 100% BY THE VISION SYSTEM, IN ADDITION TO UNDERGOING VISUAL INSPECTIONS AND FUNCTIONAL TESTS EVERY 2 HOURS. THESE METHODS WOULD BE CAPABLE OF IDENTIFYING THE MENTIONED DEFECT IF IT WERE A RECURRING ISSUE. BD'S PROCESSES ARE VALIDATED ACCORDING TO ESTABLISHED STANDARDS, ENSURING QUALITY THROUGH PERIODIC INSPECTIONS BASED ON STATISTICAL ASSURANCE. AS THIS IS THE FIRST COMPLAINT RELATED TO THE BATCH IN QUESTION, AND THE ACCEPTABLE QUALITY NOTIFICATION (NQA) LIMIT HAS NOT BEEN EXCEEDED, THE INCIDENT WILL BE MONITORED FOR TREND EVALUATION. PACKAGE DAMAGED / DEFECTIVE / OTHER THE ANALYSIS OF THE LOT HISTORY (DHR) WAS CARRIED OUT, AS WELL AS THE VERIFICATION OF QUALITY NOTIFICATIONS. BASED ON THE PHOTO SENT BY THE CUSTOMER, IT WAS POSSIBLE TO CONFIRM THE REPORTED INCIDENT. THE CUSTOMER IS CORRECT IN THEIR OBSERVATION: TWO PARTS POSITIONED IN THE SAME CAVITY CAUSE FRICTION AND LIMITED SPACE, WHICH CAN RESULT IN THE PACKAGE OPENING. THIS CONDITION HAS BEEN IDENTIFIED AS AN ISOLATED CASE AND IS BEING ADDRESSED AS PART OF THE CONTINUOUS IMPROVEMENT PROCESS. AS THIS IS THE FIRST COMPLAINT RELATED TO THE BATCH IN QUESTION, AND THE ACCEPTABLE QUALITY NOTIFICATION (NQA) LIMIT HAS NOT BEEN EXCEEDED, THE INCIDENT WILL BE MONITORED FOR TREND EVALUATION. THE VISION SYSTEMS WERE VERIFIED AND SUBJECTED TO CHALLENGE TESTS TO VALIDATE THEIR FUNCTIONALITY. THE RESULTS DEMONSTRATED THAT THEY ARE OPERATING ACCORDING TO THE ESTABLISHED PARAMETERS, MEETING THE INSPECTION CRITERIA DEFINED FOR THE PROCESS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE PRECISIONGLIDE 16X1-1/2IN PACKAGE WAS DAMAGED / DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO NEEDLES IN THE SAME PACKAGE COULD NOT BE USED BECAUSE THE NEEDLES TORE THE PAPER PACKAGING, COMPROMISING THE STERILITY OF THE PRODUCT. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 15, 2025. IS THE SAMPLE RELATED TO THIS INCIDENT AVAILABLE FOR ANALYSIS? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2557793 BD NEEDLE PRECISIONGLIDE 16X1-1/2IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA 4120571

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown