BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

    MDR report key: 12939710 · Received December 6, 2021

    Report

    Report Number
    1917413-2021-01034
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 8, 2021
    Report Date
    November 17, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JCF
    PMA / PMN Number
    K891407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, FIFTY-FOUR (54) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO GLASS BREAKAGE DURING CENTRIFUGATION AS ALL SAMPLES MET SPECIFICATIONS. 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 NOTIFICATIONS. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OF GLASS BREAKAGE DURING CENTRIFUGATION BASED ON THE RETENTION SAMPLES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CENTRIFUGATION WITH BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML THE TUBES CRACKED AND BLOOD SPLATTER OCCURRED. THIS OCCURRED WITH 120 TUBES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YESTERDAY IT HAPPENED THE THIRD TIME WITHIN THE LAST MONTHS THAT SOME OF THE CPT TUBES BREAK DURING CENTRIFUGATION. THEY CENTRIFUGE THEM AT 1650X G, 20 MIN, RT. THE TUBES WERE CORRECTLY FILLED. THIS IS WHY THEY CAN'T EXPLAIN WHY THIS HAPPENS, SPECIALLY BECAUSE ALL THE OTHER TUBES IN THE SAME CENTRIFUGE AT THE SAME CONDITIONS SHOWED NO PROBLEMS. THEY USE TUBES OF THE SAME LOT AS THEY ARE DOING A STUDY. THEY WOULD LIKE TO KNOW WHAT COULD BE THE REASON AND WHETHER IT WOULD HELP IF THEY'D REDUCE THE CENTRIFUGATION FORCE. THEY ALSO WOULD LIKE TO KNOW WHETHER WE COULD RECOMMEND A DETERGENT AS THE GEL IS VERY STICKY AND IT'S DIFFICULT TO CLEAN THE CENTRIFUGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1834768 BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML BLOOD SPECIMEN COLLECTION DEVICE JCF BECTON, DICKINSON & CO. (BROKEN BOW) 1012181

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown