BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 23720477 · Received December 4, 2025

    Report

    Report Number
    1024879-2025-01971
    Event Type
    Malfunction
    Date Received
    December 4, 2025
    Date of Event
    November 4, 2025
    Report Date
    February 26, 2026
    Manufacturer
    BECTON DICKINSON & CO (FRANKLIN LAKES)
    Product Code
    FPA
    UDI-DI
    30382903673422
    PMA / PMN Number
    K220212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE CUSTOMER-PROVIDED IMAGE SHOWS A NON-RETRACTED NEEDLE WITH THE SPRING PROTRUDING FROM THE FRONT SAMPLE. RETAINED SAMPLES CANNOT BE TESTED AS THE BATCH NUMBER IS UNKNOWN. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER IS UNKNOWN. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE: SPRING POP OUT. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. 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. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: JKA. D3. COMMON DEVICE NAME: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. LOT NUMBER WAS NOT REPORTED; HOWEVER, 2 POTENTIAL LOT NUMBERS WERE PROVIDED. THE INFORMATION FOR THESE LOT #'S ARE AS FOLLOWS: D4. MEDICAL DEVICE LOT #:5142220. D4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2027. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 01-MAY-2025. D4. MEDICAL DEVICE LOT #: 5220490. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2027. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 01-AUG-2025. 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 WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, ONE DEVICE HAD AN ISSUE DEPLOYING THE SAFETY FEATURE AND BROKE (SPRING CAME OUT). THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, ONE DEVICE HAD AN ISSUE DEPLOYING THE SAFETY FEATURE AND BROKE (SPRING CAME OUT). THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2422815 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON & CO (FRANKLIN LAKES) UNKNOWN 30382903673422

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown