BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 18809629 · Received February 29, 2024

    Report

    Report Number
    1024879-2024-00182
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    January 29, 2024
    Report Date
    May 8, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679831
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: MATERIAL #:367983, LOT/BATCH #: 3153025. BD HAD NOT RECEIVED SAMPLES, BUT ONE (1) PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WAS OBSERVED. ADDITIONALLY, TWENTY (20) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING TO DRAW TEST FOR LOW OR NO DRAW AND THE ISSUE OF UNDERFILL WAS OBSERVED. 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 OF UNDERFILLED. 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. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    (B)(6). H3. 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 DURING COLLECTION WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE, THERE WAS INSUFFICIENT NEGATIVE PRESSURE. THERE WERE NO REPORTED ADVERSE EFFECTS ON PATIENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING COLLECTION WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE, THERE WAS INSUFFICIENT NEGATIVE PRESSURE. THERE WERE NO REPORTED ADVERSE EFFECTS ON PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497328 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 3153025 50382903679831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown