BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

    MDR report key: 18588618 · Received January 26, 2024

    Report

    Report Number
    2243072-2024-00069
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    January 4, 2024
    Report Date
    February 15, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    00382903672837
    PMA / PMN Number
    K980414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL #: 367283. LOT/BATCH #: 23E08B2. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 50 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION, AND ANOTHER 8 RETENTION SAMPLES BY 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.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS NIPRO. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.5. PMA / 510(K)#: K991088 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 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THAT CUSTOMER STATES BLOOD DRIPPED FROM END OF SAFETYLOK NEEDLE ONTO FLOOR. NO PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET THAT CUSTOMER STATES BLOOD DRIPPED FROM END OF SAFETYLOK NEEDLE ONTO FLOOR. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121145 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 23E08B2 00382903672837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown