BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 23407531 · Received October 28, 2025

    Report

    Report Number
    9617032-2025-01894
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 3, 2025
    Report Date
    January 16, 2026
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903673926
    PMA / PMN Number
    K212724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INFORMATION FOR THE ADDITIONAL MEDICAL DEVICE TYPE IS AS FOLLOWS: D.2B. MEDICAL DEVICE TYPE: FPA. THE INFORMATION FOR THE ADDITIONAL COMMON DEVICE NAME IS AS FOLLOWS: D.2A. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES H.3 DEVICE EVAL BY MANUFACTURER? YES D9: RETURNED TO MANUFACTURER ON: 31-OCT-2025. INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM LOT NUMBER 5171291 FOR INVESTIGATION. A TOTAL OF THREE DEVICES FROM LOT NUMBER 5171291 UNDERWENT FUNCTIONAL TESTING, AND ALL TUBES FILLED AS EXPECTED. ADDITIONALLY, SEVEN FROM LOT NUMBER 5171291 WERE FUNCTIONALLY TESTED, AND NO ISSUES WERE OBSERVED RELATING TO INSUFFICIENT BLOOD FLOW AS ALL SAMPLES MET SPECIFICATIONS. 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 5171291 FOR THE INDICATED FAILURE MODE: INSUFFICIENT BLOOD FLOW. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    PATIENT 2 OF 10: IT WAS REPORTED WHILE USING ONE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THERE WAS INSUFFICIENT BLOOD FLOW AND NO VENOUS RETURN. THE PATIENT WAS RE-DRAWN WITH A NEW DEVICE. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    PATIENT 2 OF 10: IT WAS REPORTED WHILE USING ONE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THERE WAS INSUFFICIENT BLOOD FLOW AND NO VENOUS RETURN. THE PATIENT WAS RE-DRAWN WITH A NEW DEVICE. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841650 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 5171291 00382903673926

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown