BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 18696076 · Received February 13, 2024

    Report

    Report Number
    1917413-2024-00095
    Event Type
    Malfunction
    Date Received
    February 13, 2024
    Date of Event
    January 18, 2024
    Report Date
    February 26, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903627951
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH CORRECTED INFORMATION: D.4. MEDICAL DEVICE LOT: 3163623. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2024. H4. DEVICE MANUFACTURE DATE: 12-JUN-2023. H6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, ONE HUNDRED (100) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE RELATING TO GEL AIR BUBBLES WAS OBSERVED IN FIVE TUBES. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF JANUARY 2024. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE GEL AIR BUBBLES. 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.

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT #: 3163625 WAS REPORTED, HOWEVER, THIS IS NOT A LOT NUMBER MANUFACTURED FOR THE REPORTED CATALOG NUMBER. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. H4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, THERE WERE AIR BUBBLES IN THE GEL FOR AN UNSPECIFIED NUMBER OF TUBES. THE TUBES WERE NOT USED, AND THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG, THERE WERE AIR BUBBLES IN THE GEL FOR AN UNSPECIFIED NUMBER OF TUBES. THE TUBES WERE NOT USED, AND THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792975 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3163623 30382903627951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown