BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

    MDR report key: 18667307 · Received February 8, 2024

    Report

    Report Number
    2243072-2024-00143
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    December 14, 2023
    Report Date
    January 31, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    K980414
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.6. INVESTIGATION SUMMARY: MATERIAL #: 367294 LOT/BATCH #: 2F24A1 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 HOLE IN TUBING / 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 HOLE IN TUBING / LEAKAGE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET, A PERFORATION WAS FOUND IN THE EXTENSION TUBE OF AN INTRAVENOUS DEVICE, RESULTING IN BLOOD LEAKAGE. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2278585 BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 2F24A1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown