BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ULTRATOUCH PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 12367819 · Received August 25, 2021

    Report

    Report Number
    1024879-2021-00611
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    August 3, 2021
    Report Date
    September 1, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673648
    PMA / PMN Number
    K153309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY- BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 30 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO LEAKAGE AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE LEAKAGE. 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 IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE EXPERIENCED BLOOD SPLATTER/ LEAKAGE FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "I AM NOT SURE IF THIS IS AN ISOLATED INCIDENT, BUT ONE OF OUR LAB ASSISTANT CAME ACROSS A LEAK WHILE USING THE BUTTERFLY 23G. THEY SHOWED ME THE NEEDLE AND IT WAS LEAKING NEAR THE TOP WHERE THE PUSH BUTTON AND TUBE CONNECTS. THE LOT NUMBER WE ARE USING IS 1102596."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: FPA. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. 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 · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE EXPERIENCED BLOOD SPLATTER/ LEAKAGE FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "I AM NOT SURE IF THIS IS AN ISOLATED INCIDENT, BUT ONE OF OUR LAB ASSISTANT CAME ACROSS A LEAK WHILE USING THE BUTTERFLY 23G. THEY SHOWED ME THE NEEDLE AND IT WAS LEAKING NEAR THE TOP WHERE THE PUSH BUTTON AND TUBE CONNECTS. THE LOT NUMBER WE ARE USING IS 1102596."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262771 BD VACUTAINER ULTRATOUCH PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367364 1102596 50382903673648

    Patients

    Seq Age Sex Outcome Treatment
    1