BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 23743472 · Received December 8, 2025

    Report

    Report Number
    9617032-2025-02154
    Event Type
    Malfunction
    Date Received
    December 8, 2025
    Date of Event
    July 17, 2025
    Report Date
    February 26, 2026
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903673643
    PMA / PMN Number
    K212724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9: DEVICE AVAILABLE FOR EVALUATION: YES . H.3 DEVICE EVAL BY MANUFACTURER? YES . D9: RETURNED TO MANUFACTURER ON: 27-NOV-2025 . INVESTIGATION SUMMARY: BD RECEIVED ONE SAMPLE AND THREE PHOTOS WERE PROVIDED FOR INVESTIGATION. THE EVALUATION OF BOTH REVEALED A CRACK IN THE LUER ADAPTER. FURTHERMORE, TEN RETAINED SAMPLES WERE VISUALLY INSPECTED, AND NO SPLIT FEMALE LUER ADAPTERS WERE FOUND. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: DAMAGED. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF CRACKED FEMALE LUERS THROUGH CORRECTIVE AND PREVENTIVE ACTIONS COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    D2B: ADDITIONAL MEDICAL DEVICE TYPE: FPA. E1: INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, CRACKS WERE VISIBLE IN THE LUER ADAPTER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING ONE (1) BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, CRACKS WERE VISIBLE IN THE LUER ADAPTER. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356245 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET JKA BECTON, DICKINSON AND COMPANY (BD) 4306998 00382903673643

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown