BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 18X1-1/2 RB TW

    MDR report key: 24449402 · Received February 25, 2026

    Report

    Report Number
    3002682307-2026-00009
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    February 11, 2026
    Report Date
    April 20, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PHYSICAL SAMPLE AND ONE (1) PICTURE SAMPLE WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLE, WHITE DROPS (THE EPOXY USED TO BOND THE CANNULA INTO THE HUB) WERE OBSERVED ON THE CANNULA COMPONENT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303262 AND LOT NUMBER 250601. A NON-CONFORMANCE WAS RAISED FOR A MALFUNCTION OF THE EPOXY DOSAGE. THE PRODUCT WAS SEGREGATED AND ACCEPTED. AS PER THE INVESTIGATION, IT SEEMS THAT THE SEGREGATION PROCESS WAS NOT PERFORMED CORRECTLY AND SOME DEFECTIVE PRODUCT LEFT THE MANUFACTURING SITE. THIS ISSUE LIKELY OCCURRED DURING THE ASSEMBLY PROCESS, SPECIFICALLY AT THE STAGE WHERE EPOXY IS DISPENSED INTO THE HUB. IT MAY HAVE BEEN CAUSED BY A TEMPORARY STOPPAGE OR A MALFUNCTION IN THE EPOXY DISPENSING EQUIPMENT. AS A RESULT, AN EXCESSIVE AMOUNT OF EPOXY WAS APPLIED, WHICH THEN OVERFLOWED ONTO THE SUBSEQUENT CANNULA, LEADING TO THE OBSERVED DEFECT. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THE PROBABILITY OF THIS DEFECT IS VERY LOW WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 18X1-1/2 RB TW HAD EPOXY ON THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REFERENCE: 303262 BATCH: 250601 QTY: 1 DATE OF OCCURRENCE: (B)(6) 2026. IT WAS REPORTED THAT "PRESENCE OF HARDENED WHITE FILM ON THE NEEDLE WHEN OPENED" CLINICAL CONSEQUENCES OBSERVED: NONE ACTION TAKEN: USE OF ANOTHER DEVICE AVAILABLE FOR REPLACEMENT: YES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567314 BD NEEDLE 18X1-1/2 RB TW NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON, S.A. 250601

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown