BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 24576953 · Received March 12, 2026

    Report

    Report Number
    1024879-2026-00338
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    February 9, 2026
    Report Date
    May 8, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    FPA
    UDI-DI
    00382903673643
    PMA / PMN Number
    K212724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE NEW INFORMATION IN SECTION E1: INITIAL REPORTER ADDR 1 AND INITIAL REPORTER CITY. INVESTIGATION SUMMARY: BD RECEIVED TWO SAMPLES AND TWO PHOTOS FOR INVESTIGATION. ONE CUSTOMER PHOTO SHOWED A DEVICE WITH A CUT OR HOLE IN THE TUBING, WHILE THE SECOND PHOTO DISPLAYED BLOOD LEAKAGE FROM THE TUBING. BOTH CUSTOMER SAMPLES WERE SUBJECTED TO VISUAL INSPECTION FOR CUT OR DAMAGED TUBING: HOWEVER, ALL SAMPLES FAILED TESTING AS THEY WERE RECEIVED USED AND EXHIBITED CUTS IN THE TUBING. BD IS ABLE TO CONFIRM THE CUSTOMER REPORTED FAILURE MODE OF DAMAGED / CUT PRODUCT/COMPONENT FOR LOT 5241478 BASED ON CUSTOMER PHOTO ANALYSIS AND THE RETURNED SAMPLES. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE AFFECTED LOT, ALL PRODUCT SPECIFICATIONS AND LOT RELEASE REQUIREMENTS WERE MET. REVIEW OF THE BATCH RECORDS DID NOT IDENTIFY ANY MANUFACTURING RELATED ROOT CAUSE OR QUALITY ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. 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.

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, BLOOD LEAKED FROM THREE (3) DEVICES. 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 BLOOD COLLECTION SET, BLOOD LEAKED FROM THREE (3) DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON & CO (FRANKLIN LAKES) 5241478 00382903673643

    Patients

    Seq Age Sex Outcome Treatment
    1