BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 18094298 · Received November 8, 2023

    Report

    Report Number
    1024879-2023-00791
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 20, 2023
    Report Date
    February 15, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FPA
    UDI-DI
    50382903673631
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES D.9:DEVICE EVAL BY MANUFACTURER? YES D9: RETURNED TO MANUFACTURER ON: 2023-NOVEMBER -9TH H.6 INVESTIGATION SUMMARY: MATERIAL #: 367363. LOT/BATCH #: 2080580. BD RECEIVED 5 SAMPLES AND 2 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR DISCOLORED TUBING WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR DISCOLORED TUBING WITH THE INCIDENT LOT WAS NOT OBSERVED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE DISCOLORED TUBING. 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.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: D2B: MEDICAL DEVICE TYPE: JKA. H3. 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 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BUTTERFLY KIT HAD TUBING THAT HAD A DISCOLORED (YELLOWISH) SECTION. ALL 50 TUBES FROM LAST REMAINING KIT WERE INSPECTED BEFORE USE AND FOUND TO BE AFFECTED AND WERE NOT USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BUTTERFLY KIT HAD TUBING THAT HAD A DISCOLORED (YELLOWISH) SECTION. ALL 50 TUBES FROM LAST REMAINING KIT WERE INSPECTED BEFORE USE AND FOUND TO BE AFFECTED AND WERE NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923196 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET FPA BECTON, DICKINSON & CO., (BD) 2080580 50382903673631

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown