BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    MDR report key: 16940513 · Received May 16, 2023

    Report

    Report Number
    1917413-2023-00438
    Event Type
    Malfunction
    Date Received
    May 16, 2023
    Date of Event
    April 24, 2023
    Report Date
    June 21, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627603
    PMA / PMN Number
    K911731
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 362760. LOT/BATCH #: 2173885. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, (B)(4) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO POOR BARRIER SEPARATION AS ALL SAMPLES MET SPECIFICATIONS. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF APRIL 2023. 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE [XX]. 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.

    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

    IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE THERE WAS POOR BARRIER SEPARATION OF THE SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, THE LAYER OF MONONUCLEAR CELLS IS LOWER THAN THE SEPARATOR. IT LOOKS DIFFERENT FROM THE USUAL TUBES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE THERE WAS POOR BARRIER SEPARATION OF THE SAMPLE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, THE LAYER OF MONONUCLEAR CELLS IS LOWER THAN THE SEPARATOR. IT LOOKS DIFFERENT FROM THE USUAL TUBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638172 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 362760 2173885 50382903627603

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown