BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE

    MDR report key: 20410341 · Received October 9, 2024

    Report

    Report Number
    9617032-2024-01633
    Event Type
    Malfunction
    Date Received
    October 9, 2024
    Date of Event
    July 9, 2024
    Report Date
    November 11, 2024
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679534
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BATCH #: 4043969 AND 3122471. BD HAD NOT RECEIVED SAMPLES, BUT FOUR (4) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR GEL AIR BUBBLES BEFORE USE WAS OBSERVED, BUT OIL GEL GLOBULES WAS NOT SEEN. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION FOR ALL GEL DEFECTS, AND THE ISSUE OF GEL AIR BUBBLES AND OIL GEL GLOBULES WERE NOT OBSERVED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF SEPTEMBER 2024. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. 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 GEL AIR BUBBLES- BEFORE USE BASED ON THE PHOTO ANALYSIS, BUT UNCONFIRMED FOR OIL GEL GLOBULES. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Additional Manufacturer Narrative · 0

    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

    REPORT 3 OF 3: IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THAT THERE WERE INCIDENCES OF GEL RESIDUES IN THE SERUMS AND THAT JAMMED THE NEEDLES OF THE ANALYTICAL MACHINES. NO PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 3 OF 3: IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES THAT THERE WERE INCIDENCES OF GEL RESIDUES IN THE SERUMS AND THAT JAMMED THE NEEDLES OF THE ANALYTICAL MACHINES. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714796 BD VACUTAINER® SST¿ II ADVANCE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3122471 50382903679534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown