BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

    MDR report key: 18170584 · Received November 20, 2023

    Report

    Report Number
    2243072-2023-02071
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    October 23, 2023
    Report Date
    December 26, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    00382903672837
    PMA / PMN Number
    K980414
    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-DECEMBER -5TH. H.6 INVESTIGATION SUMMARY: MATERIAL #: 367283. LOT/BATCH #: 23C26B1. BD RECEIVED 5 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING, EACH USED TO DRAW 10 VACUTAINER TUBES, AND THE INDICATED FAILURE MODE FOR SLEEVE LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 8 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING, EACH USED TO DRAW 10 VACUTAINER TUBES, AND NO ISSUES WERE OBSERVED RELATING TO SLEEVE LEAKAGE AS ALL SAMPLES MET SPECIFICATIONS. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE SLEEVE 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. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. IN THIS MDR, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AS DC US PLAINFIELD IN IS AN OEM MANUFACTURING SITE. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: K980414 AND K991088.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THAT SINGLE INCIDENT OF BLOOD LEAKAGE OCCURRED WHILE SWITCHING TUBES DURING COLLECTION. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THAT SINGLE INCIDENT OF BLOOD LEAKAGE OCCURRED WHILE SWITCHING TUBES DURING COLLECTION. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991713 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 23C26B1 00382903672837

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown