BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ULTRATOUCH PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 12104277 · Received July 1, 2021

    Report

    Report Number
    9617032-2021-00698
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    June 7, 2021
    Report Date
    July 16, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903673921
    PMA / PMN Number
    K153309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD DID NOT RECEIVE SAMPLES OR PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THEREFORE, 30 RETAINED PARTS FROM THE ASSOCIATED BATCH (1060479) WERE TESTED FOR CORRECT RETRACTION, ALL PARTS FUNCTIONED CORRECTLY, FULLY RETRACTING THE IV CANNULA. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. 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 IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE EXPERIENCED RETRACTION ISSUE - DOES NOT RETRACT (BUTTON WILL NOT ENGAGE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DURING THE USE OF AN EPICRANIAN TODAY, IT WAS IMPOSSIBLE TO ACTIVATE THE SAFETY SYSTEM ALLOWING THE NEEDLE TO BE RETRACTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 RETRACTION ISSUE - DOES NOT RETRACT (BUTTON WILL NOT ENGAGE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DURING THE USE OF AN EPICRANIAN TODAY, IT WAS IMPOSSIBLE TO ACTIVATE THE SAFETY SYSTEM ALLOWING THE NEEDLE TO BE RETRACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    997261 BD VACUTAINER ULTRATOUCH PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367392 1060479 50382903673921

    Patients

    Seq Age Sex Outcome Treatment
    1