BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON

    MDR report key: 24634899 · Received March 18, 2026

    Report

    Report Number
    1024879-2026-00384
    Event Type
    Malfunction
    Date Received
    March 18, 2026
    Date of Event
    February 9, 2026
    Report Date
    April 20, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    FPA
    UDI-DI
    30382903686866
    PMA / PMN Number
    K212724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED ANY SAMPLES OR PHOTOS FOR INVESTIGATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOT 5020089, FOR THE INDICATED FAILURE MODE: INSUFFICIENT BLOOD FLOW. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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

    D2A. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: JKA. D2B. COMMON DEVICE NAME: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION. 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

    REPORT 2 OF 2 IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON, INSUFFICIENT BLOOD FLOW WAS SEEN WITH AN UNSPECIFIED NUMBER OF DEVICES. ONLY A FEW DROPS WERE COLLECTED FROM THE FIRST SAMPLE, WHILE THE SECOND SAMPLE REMAINED EMPTY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON, INSUFFICIENT BLOOD FLOW WAS SEEN WITH AN UNSPECIFIED NUMBER OF DEVICES. ONLY A FEW DROPS WERE COLLECTED FROM THE FIRST SAMPLE, WHILE THE SECOND SAMPLE REMAINED EMPTY. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695860 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON & CO (FRANKLIN LAKES) 5020089 30382903686866

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown