BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES

    MDR report key: 18966568 · Received March 24, 2024

    Report

    Report Number
    1917413-2024-00228
    Event Type
    Malfunction
    Date Received
    March 24, 2024
    Date of Event
    February 5, 2024
    Report Date
    April 17, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    30382903678618
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT FROM CATALOG 367861, LOT NUMBER 3222727. NO CUSTOMER SAMPLES AND NO PHOTOS WERE RECEIVED; THEREFORE, THE INVESTIGATION WAS LIMITED. 100 RETENTIONS WERE VISUALLY INSPECTED WITH THE HEMOGARD CLOSURE ASSEMBLY CORRECTLY ASSEMBLED AND PLACED ON THE TUBES. A DRAW TEST WAS PERFORMED AT THE MANUFACTURING SITE ON 10-PRODUCTION LOT IN-HOUSE RETENTION TUBES. ALL TUBES WERE WITHIN SPECIFICATION LIMITS WITH NO ISSUES IDENTIFIED. THE QUANTITY OF BLOOD DRAWN VARIES WITH ALTITUDE, AMBIENT TEMPERATURE, BAROMETRIC PRESSURE, AGE OF THE TUBE, VENOUS PRESSURE AND FILLING TECHNIQUE. TUBES WITH SMALLER DRAW VOLUMES (PARTIAL DRAW TUBES DENOTED BY TRANSLUCENT CLOSURES) MAY FILL MORE SLOWLY, DUE TO THE LOWER VACUUM, THAN TUBES OF THE SAME SIZE WITH LARGER DRAW VOLUMES. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE WITH THE INVESTIGATION COMPLETED. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    Additional Manufacturer Narrative · 0

    D.2. MEDICAL DEVICE TYPE: GIM G.2. PMA / 510(K)#: K213670 E.4. INITIAL REPORTER FACILITY NAME: THE FIRST AFFILIATED HOSPITAL OF (B)(6) H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES THERE WAS A NEGATIVE PRESSURE IN THE TUBE (UNDERFILLED). THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES THERE WAS A NEGATIVE PRESSURE IN THE TUBE (UNDERFILLED). THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13731 BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 3222727 30382903678618

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown