BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG

    MDR report key: 20327703 · Received September 27, 2024

    Report

    Report Number
    1917413-2024-00917
    Event Type
    Malfunction
    Date Received
    September 27, 2024
    Date of Event
    August 30, 2024
    Report Date
    October 4, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    PJE
    UDI-DI
    30382903627951
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, 100 RETENTION SAMPLES FROM BD INVENTORY WERE VISUALLY INSPECTED AND 2 TUBES CONTAINED A GEL AIR BUBBLE. NO TUBES CONTAINED FOREIGN MATTER(FM). 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. IT HAS NOT BEEN CONFIRMED FOR FM. BD WAS NOT ABLE TO IDENTIFY AN EXACT ROOT CAUSE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG AN UNSPECIFIED NUMBER OF TUBES HAD GEL AIR BUBBLES AND/OR FOREIGN MATTER(FM). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG AN UNSPECIFIED NUMBER OF TUBES HAD GEL AIR BUBBLES AND/OR FOREIGN MATTER(FM). THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664042 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E 9.0 MG BLOOD/PLASMA COLLECTION DEVICE FOR DNA TESTING PJE BECTON, DICKINSON & CO. (BROKEN BOW) 4102179 30382903627951

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown