BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 18328814 · Received December 14, 2023

    Report

    Report Number
    1024879-2023-00900
    Event Type
    Malfunction
    Date Received
    December 14, 2023
    Date of Event
    November 21, 2023
    Report Date
    March 5, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FPA
    UDI-DI
    50382903673266
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL? YES. RETURNED TO MANUFACTURER ON 29-FEB-24. DEVICE RETURN TO MANUF .? YES. DEVICE EVAL BY MANUFACTURER? YES. INVESTIGATION EXEC SUMMARY: MATERIAL #: 367326. LOT/BATCH #: 3104074. BD RECEIVED THREE (3) SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR LEAKAGE WITH THE INCIDENT LOT WAS OBSERVED. ALL THREE SAMPLES FAILED TESTING. ONE OF THE SAMPLES THE TUBING APPEARED SLICE WITH BLOOD LEAKAGE THROUGH THE CUT. ANOTHER OF THE SAMPLES HAD BLOOD LEAKAGE ON THE SLEEVE. THE LAST SAMPLE HAD BLOOD LEAKAGE AROUND THE LUER OF THE DEVICE. 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 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.

    Additional Manufacturer Narrative · 0

    D.1 REQUIRED FIELD IN THE NEXT STATE MEDICAL DEVICE TYPE: FPA, JKA. E.1 INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. G.5 PMA / 510(K)#K030573, K220212. H.3. 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 WHILE USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THAT THERE WAS A BLOOD LEAK. NO PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THAT THERE WAS A BLOOD LEAK. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326499 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET FPA BECTON, DICKINSON & CO., (BD) 3104074 50382903673266

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown