BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ORAL SYRINGE

    MDR report key: 24184863 · Received January 26, 2026

    Report

    Report Number
    1213809-2026-00028
    Event Type
    Malfunction
    Date Received
    January 26, 2026
    Date of Event
    January 13, 2026
    Report Date
    February 20, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    KYW
    UDI-DI
    30382903052104
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. SIX PHOTOS OF 3 ML AMBER ORAL SYRINGES PART NUMBER 305210 WERE REVIEWED, REVEALING MULTIPLE NON CONFORMING CONDITIONS. THE IMAGES SHOWED SYRINGES WITH CRACKED AND BENT PLUNGER RODS, PLUNGER ROD DAMAGE AFFECTING MULTIPLE UNITS, MISSING AND SKEWED SCALE MARKINGS, BARREL FLANGE DAMAGE, AND BLACK DISCOLORATION ON A PLUNGER ROD. THESE OBSERVED DEFECTS DO NOT MEET PRODUCT SPECIFICATIONS. THE LIKELY ROOT CAUSES INCLUDE THE MOLDING PROCESS FOR EMBEDDED FOREIGN MATTER, THE MARKING PROCESS FOR BARREL DAMAGE AND SKEWED SCALE DEFECTS, AND THE ASSEMBLY PROCESS FOR DAMAGE TO THE PLUNGER RODS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 305210, LOT 4278622. ALL IN PROCESS AND FINAL VISUAL INSPECTIONS WERE PERFORMED AS REQUIRED, AND NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. THE LOT MET ACCEPTANCE CRITERIA PER THE INSPECTION CONTROL PLAN, WAS APPROVED FOR SHIPMENT, AND IS IN COMPLIANCE WITH APPLICABLE PRODUCT SPECIFICATIONS.

    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

    IT WAS REPORTED THAT THE BD SYRINGE ORAL 3ML AMBER HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT ADDITIONAL ISSUES FOR THE BUCCOLAM SYRINGES. CONSIDERING THE VOLUMES OF DEFECTS THAT WE WERE OBSERVING IN THE DOSED SYRINGES, ONE BATCH OF INCOMING PRODUCT AD052001 BUCCOLAM SYRINGE 3ML LOT 100941 HAS BEEN REVIEWED. 23,000 SYRINGES FROM BATCH AD052001, LOT 100941, WERE INSPECTED BEFORE BEING LOADED INTO THE DOSING MACHINE (DIRECTLY FROM THE SUPPLIER). THE FOLLOWING DEFECTS WERE FOUND: SYRINGES WITH MISALIGNED PRINTING: (B)(4) UNITS SYRINGES WITH STAINED PLUNGERS: (B)(4) UNITS SYRINGES WITH BROKEN OR CRACKED PLUNGERS: (B)(4) UNITS SYRINGES WITH A NOTCH IN THE PLUNGER: (B)(4) UNITS SYRINGES WITH BENT PLUNGERS: (B)(4) UNITS FIND PICTURES IN THE ATTACHED DOCUMENT. NOTE THAT OUR REFERENCE FOR THE CASE IS (B)(4). BEFORE USE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244394 BD ORAL SYRINGE CONTAINER, LIQUID MEDICATION, GRADUATED KYW BECTON DICKINSON MEDICAL SYSTEMS 4278622 30382903052104

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown