BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD EDTA TUBE

    MDR report key: 9592128 · Received January 15, 2020

    Report

    Report Number
    2243072-2020-00039
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    September 23, 2019
    Report Date
    March 5, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY THE CUSTOMER DID NOT PROVIDE BD PAS WITH PRODUCT CATALOG NUMBER OR LOT NUMBER INFORMATION, WHEN REQUESTED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. AFTER 3-FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, BD PAS HAS CLOSED THIS CUSTOMER COMPLAINT. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD EDTA TUBE EXPERIENCED ERRONEOUS RESULTS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN . BATCH NO. UNKNOWN . COMPLAINT 5 OF 7 (B)(6) 2019 . 51 YEAR OLD FEMALE PLATELET COUNT 92 (1ST RUN) UPDATE: INCONSISTENT PLATELETS COUNT RESULTS. CUSTOMER IS HAVING FREQUENT LOW PLATELET COUNT USING THE BD EDTA TUBE SINCE THE PAST YEAR. ALSO THEY ARE HAVING MANY UNDER FILLING OF GOLD TOP SST TUBE HAPPENING FREQUENTLY. NO LOT NUMBER(S) PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD EDTA TUBE EXPERIENCED ERRONEOUS RESULTS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN. COMPLAINT 5 OF 7 . (B)(6) 2019. (B)(6) YEAR OLD FEMALE. PLATELET COUNT 92 (1ST RUN). UPDATE: INCONSISTENT PLATELETS COUNT RESULTS. CUSTOMER IS HAVING FREQUENT LOW PLATELET COUNT USING THE BD EDTA TUBE SINCE THE PAST YEAR. ALSO THEY ARE HAVING MANY UNDER FILLING OF GOLD TOP SST TUBE HAPPENING FREQUENTLY. NO LOT NUMBER(S) PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57348 UNSPECIFIED BD EDTA TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other