BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E

    MDR report key: 13713728 · Received March 9, 2022

    Report

    Report Number
    1917413-2022-00117
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    February 28, 2022
    Report Date
    March 15, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    PJE
    UDI-DI
    50382903627887
    PMA / PMN Number
    K972075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES, BUT 4 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR AIRBUBBLES IN THE GEL AND LOW QUANTITY OF GEL WAS OBSERVED. ADDITIONALLY, 95 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF GEL AIR BUBBLES AND INSUFFICIENT GEL QUANTITY WAS NOT OBSERVED. 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 GEL AIR BUBBLES AND INSUFFICIENT GEL QUANTITY. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE OF THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E THERE WERE AIR BUBBLES IN THE GEL AND UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE GEL AIR BUBBLES AFFECTED 228 DEVICES. THE UNDERFILL ISSUE AFFECTED 3 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BEFORE USE, THE TUBES WERE FOUND TO HAVE A GEL AIR BUBBLE AND GEL VOLUME INSUFFICIENT ISSUE."

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE OF THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E THERE WERE AIR BUBBLES IN THE GEL AND UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE GEL AIR BUBBLES AFFECTED 228 DEVICES. THE UNDERFILL ISSUE AFFECTED 3 DEVICES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BEFORE USE, THE TUBES WERE FOUND TO HAVE A GEL AIR BUBBLE AND GEL VOLUME INSUFFICIENT ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2759904 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON & CO. (BROKEN BOW) 362788 1165540 50382903627887

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown