BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 19116767 · Received April 16, 2024

    Report

    Report Number
    1024879-2024-00341
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    February 29, 2024
    Report Date
    May 22, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903679868
    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

    MULTIPLE LOT NUMBERS: D4. MEDICAL DEVICE LOT #: 3201200. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2024. H4. DEVICE MANUFACTURE DATE: 20-JUL-2023. D4. MEDICAL DEVICE LOT #: 3145847. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024. H4. DEVICE MANUFACTURE DATE: 25-MAY-2023. D4. MEDICAL DEVICE LOT #: 3201199. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2024. H4. DEVICE MANUFACTURE DATE: 20-JUL-2023. E1. INITIAL REPORTER PHONE #: (B)(6). INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D.9:DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 13-MAY-2024. H.6 INVESTIGATION SUMMARY: BD RECEIVED TWO (2) SAMPLES FOR BATCH 3201200 AND THREE (3) PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR HEMOLYSIS WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH THIRTY (30) RETENTION SAMPLES (OF EACH REPORTED BATCH) FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF MARCH 2024. IF COMPLAINTS FOR SAMPLE QUALITY REACH AN ACTION LEVEL, ADDITIONAL TESTING MAY BE REQUIRED. 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. BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THREE OF THE REPORTED INCIDENCES OF HEMOLYSIS; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED FOR THE UNKNOWN BATCHES. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF HEMOLYSIS BASED ON PHOTO ANALYSIS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, HEMOLYSIS OCCURRED WITH AN UNSPECIFIED NUMBER OF TUBES. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 1 OF 4.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, HEMOLYSIS OCCURRED WITH AN UNSPECIFIED NUMBER OF TUBES. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 1 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262622 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H10 30382903679868

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown