BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 17612355 · Received August 24, 2023

    Report

    Report Number
    1024879-2023-00595
    Event Type
    Malfunction
    Date Received
    August 24, 2023
    Date of Event
    August 8, 2023
    Report Date
    October 10, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 29-AUG-2023. H.6. INVESTIGATION SUMMARY: CATALOG NUMBER: 367979. BATCH NUMBER: 3153018. TWO CUSTOMER SAMPLES AND THREE CUSTOMER PHOTOS WERE RECEIVED FOR REVIEW AND ANALYSIS. AFTER REVIEW AND ANALYSIS OF THE CUSTOMER PHOTOS, ADDITIVE RUNDOWN CAN BE SEEN IN BOTH TUBES. ADDITIONALLY, 2 CUSTOMER SAMPLES WERE SUBJECTED TO A VISUAL INSPECTION FOR ADDITIVE ABNORMALITY. 2 OF 2 FAILED. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. THIS COMPLAINT HAS BEEN CONFIRMED FOR ADDITIVE ABNORMALITY BASED ON THE PHOTOS PROVIDED AND TESTING OF THE CUSTOMER RETURNED SAMPLES. BD WAS UNABLE TO DETERMINE ROOT CAUSE. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    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 WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD ABNORMAL SPRAY COAT IN THE TUBE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "SILICA'S DOT OF SPRAY COAT IS TOO BIG.".

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD ABNORMAL SPRAY COAT IN THE TUBE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "SILICA'S DOT OF SPRAY COAT IS TOO BIG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2113857 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 3153018

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown