BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 15423411 · Received September 14, 2022

    Report

    Report Number
    1024879-2022-00529
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    August 22, 2022
    Report Date
    September 28, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673648
    PMA / PMN Number
    K153309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2094363. MEDICAL DEVICE EXPIRATION DATE: 2024-03-31. DEVICE MANUFACTURE DATE: 2022-04-04. MEDICAL DEVICE LOT #: 2193159. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. DEVICE MANUFACTURE DATE: 2022-07-12.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL? YES. D9: RETURNED TO MANUFACTURER ON: 29-AUG-2022. H.6. INVESTIGATION SUMMARY: CATALOG NUMBER: 367364. BATCH NUMBER: 2094363 AND 2193159. BD RECEIVED 2 CUSTOMER PHOTOS, 3 CUSTOMER SAMPLES FROM BATCH 2094363 AND 4 CUSTOMER SAMPLES FROM BATCH 2193159 WERE RECEIVED FOR REVIEW AND ANALYSIS. THE CUSTOMER PHOTOS WERE EVALUATED AND DO NOT SHOW ANY EVIDENCE OF LEAKAGE AS THEY ARE PICTURES OF THE BOX, SO THE REPORTED FAILURE MODE OF LEAKAGE CANNOT BE CONFIRMED BASED ON CUSTOMER PHOTO ANALYSIS. THE CUSTOMER SAMPLES FROM BATCH 2193159 AND BATCH 2094363 WERE SUBJECTED TO FUNCTIONAL TESTING AND THERE WERE NO ISSUES OBSERVED RELATING TO LEAKAGE. BD IS UNABLE TO CONFIRM THE CUSTOMER¿S REPORTED FAILURE MODE OF LEAKAGE BASED ON CUSTOMER SAMPLE TESTING RESULTS. BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE CUSTOMER¿S REPORTED ISSUE. THE DEVICE HISTORY RECORD WAS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WINGSET IS EXPERIENCING LEAKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED BY THE CUSTOMER THAT WINGSET IS EXPERIENCING LEAKING ISSUES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET WINGSET IS EXPERIENCING LEAKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT WINGSET IS EXPERIENCING LEAKING ISSUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250340 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367364 2193159 50382903673648

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown