BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROTAINER TUBES WITH K2E (K2EDTA)

    MDR report key: 10921460 · Received November 30, 2020

    Report

    Report Number
    2618282-2020-00099
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Date of Event
    November 10, 2020
    Report Date
    December 30, 2020
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    UDI-DI
    50382903659741
    PMA / PMN Number
    K991702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES OR PHOTOS WERE RECEIVED FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. FIFTY (50) RETENTION SAMPLES WERE EVALUATED FOR VISUAL PRESENCE OF ADDITIVE WITH ACCEPTABLE RESULTS. FIFTEEN (15) SAMPLES REPRESENTING EACH SOLUTION DISPENSE POSITION PRESENT IN THE RETENTION SAMPLES WERE EVALUATED FOR QUANTITY OF ADDITIVE VIA TITRATION TESTING. ONE (1) SAMPLE FROM DISPENSE POSITION 1 WAS IDENTIFIED TO CONTAIN 1.29 MG OF K2EDTA, WHICH IS ABOVE THE ACCEPTABLE LIMITS OF 0.75 MG-1.25 MG K2EDTA. THE TITRATION RESULTS OF THE REMAINING RETENTION SAMPLES TESTED WERE FOUND WITHIN ACCEPTABLE LIMITS OF 0.75- 1.25 MG OF K2EDTA. PER QA LABORATORY INVESTIGATION OOS 20-012, AN ADDITIONAL SAMPLE WAS TESTED FROM THE SAME POSITION WITH ACCEPTABLE RESULTS AND BOTH TEST RESULTS WERE FOUND TO BE VALID. SINCE ONE POSITION (DISPENSE POSITION 1) WAS IDENTIFIED WITH HIGH QUANTITY OF K2EDTA, THE ISSUE MAY HAVE BEEN DUE TO WORN DISPENSE SYSTEM COMPONENTS (TRANSDUCER). IF FAILURE OF THE ADDITIVE DISPENSE SYSTEM (OR CRITICAL SYSTEM COMPONENTS) OCCUR, THE EVENTS ARE READILY EVIDENT AND THE FAILURE MODE IS USUALLY CONSISTENT; WITH THE PROCESS CONTROLS IN PLACE THE ADDITIVE WEIGHTS AND/OR SPRAY PATTERNS WILL BE DETECTED TO BE OUT OF SPECIFICATION. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED FOR THE INCIDENT LOT. ONE (1) INCIDENT RELATED TO THE DISPENSE STATION WAS REPORTED AND RESOLVED WITH ACCEPTABLE RESULTS. TO DATE NO CUSTOMER SAMPLES OR PHOTOS FROM LOT 9162833 HAVE BEEN RECEIVED FOR EVALUATION. THE ISSUE REPORTED BY THE CUSTOMER WAS CLOTTING OF THE BLOOD SAMPLE AND INSUFFICIENT QUANTITY OF ADDITIVE MAY CONTRIBUTE TO THIS ISSUE, NEVERTHELESS NO RETENTION SAMPLE TITRATION TEST RESULTED IN VALUES BELOW THE MINIMUM QUANTITY OF 0.75 MG OF K2EDTA. BASED ON THE INVESTIGATION THE REPORTED CONDITION WAS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD MICROTAINER® TUBES WITH K2E (K2EDTA) EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED THE TUBES ARE CLOTTING. BLOOD OBTAINED VIA HEEL STICK INTO MICROTAINER FOR ANALYSIS SPECIMEN CLOTTED. PATIENT HAD TO BE REDRAWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD MICROTAINER® TUBES WITH K2E (K2EDTA) EXPERIENCED CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED THE TUBES ARE CLOTTING. BLOOD OBTAINED VIA HEEL STICK INTO MICROTAINER FOR ANALYSIS SPECIMEN CLOTTED. PATIENT HAD TO BE REDRAWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386823 BD MICROTAINER TUBES WITH K2E (K2EDTA) BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 365974 9162833 50382903659741

    Patients

    Seq Age Sex Outcome Treatment
    1