BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN BLOOD COLLECTION TUBES

    MDR report key: 15906271 · Received December 2, 2022

    Report

    Report Number
    1917413-2022-00759
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    November 11, 2022
    Report Date
    December 13, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679626
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLE AND 1 PHOTO WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT FROM CATALOG 367962, LOT NUMBER 2080690. THE PHOTO SHOWS A SHELF PACK OF 100 TUBES WITH THE SHRINKWRAP STILL ON THE PRODUCT. THE PHOTO DOES NOT SHOW THE CUSTOMER¿S FAILURE MODE OF STOPPER POP OFF AND DAMAGE. THE 90 RETENTION SAMPLES WERE VISUALLY INSPECTED WITH THE HEMOGARD CLOSURE ASSEMBLY CORRECTLY ASSEMBLED AND PLACED ON THE TUBES. THERE WERE NO COCKED STOPPERS IDENTIFIED THAT WOULD CAUSE THE HEMOGARD CLOSURE ASSEMBLY TO NOT BE APPLIED CORRECTLY. 10 RETENTION SAMPLES WERE DRAW TESTED WITH ALL WEIGHTS BEING WITHIN SPECIFICATION. NO ISSUES WITH THE HEMOGARD CLOSURE ASSEMBLY BEING LOOSE OR SEPARATING DURING OR AFTER THE DRAW TESTING WAS COMPLETED. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE PHOTO DID NOT SHOW THE FAILURE MODE AND RETENTION SAMPLES DID NOT EXHIBIT THE CUSTOMER¿S FAILURE MODE OF ¿STOPPER POP OFF AND DAMAGED¿. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN BLOOD COLLECTION TUBE THE STOPPER POPS OUT OF THE TUBE AND CRACKED TUBE. THE STOPPER POP OFF EVENT OCCURRED 27 TIMES. THE STOPPER CRACKED TUBE EVENT OCCURRED 27 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING THE AIR DELIVERY PROCESS, THE TUBE BURST DUE TO THE LOOSENING OF THE TUBE COVER."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN BLOOD COLLECTION TUBE THE STOPPER POPS OUT OF THE TUBE AND CRACKED TUBE. THE STOPPER POP OFF EVENT OCCURRED 27 TIMES. THE STOPPER CRACKED TUBE EVENT OCCURRED 27 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING THE AIR DELIVERY PROCESS, THE TUBE BURST DUE TO THE LOOSENING OF THE TUBE COVER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371810 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367962 2080690 50382903679626

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown