BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 9142162 · Received October 1, 2019

    Report

    Report Number
    1024879-2019-01734
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Date of Event
    September 16, 2019
    Report Date
    October 10, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673648
    PMA / PMN Number
    K153309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SETS EXPERIENCED BLOOD SPATTER/LEAKAGE AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367364, BATCH NO. 9009818. EMAIL: WE¿VE HAD A FEW INCIDENTS (5-10) OVER THE WEEKEND OF BLOOD LEAKING FROM THE TUBING ON THE ULTRATOUCH 23G. ONE OF OUR TEAM EXPERIENCED TWO INCIDENTS OF THE NEEDLE NOT RETRACTING AFTER THE BUTTON WAS AUDIBLY DEPLOYED. THE AFFECTED LOT # IS 9009818. I¿VE WITHDRAWN TWO BOXES IN THE LAB, BUT THESE ARE STOCKED THROUGHOUT THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE TYPE: JKA, FPA. 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 THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SETS EXPERIENCED BLOOD SPATTER/LEAKAGE AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367364, BATCH NO. 9009818. EMAIL: WE¿VE HAD A FEW INCIDENTS (5-10) OVER THE WEEKEND OF BLOOD LEAKING FROM THE TUBING ON THE ULTRATOUCH 23G. ONE OF OUR TEAM EXPERIENCED TWO INCIDENTS OF THE NEEDLE NOT RETRACTING AFTER THE BUTTON WAS AUDIBLY DEPLOYED. THE AFFECTED LOT # IS 9009818. I¿VE WITHDRAWN TWO BOXES IN THE LAB, BUT THESE ARE STOCKED THROUGHOUT THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937334 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET JKA BECTON, DICKINSON & CO., (BD) 9009818 50382903673648

    Patients

    Seq Age Sex Outcome Treatment
    1 Other