BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE CIT PLH 13X75 2.7 109 USI L-MG CE

    MDR report key: 13604740 · Received February 25, 2022

    Report

    Report Number
    9617032-2022-00137
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    February 15, 2022
    Report Date
    March 1, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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

    H.6. INVESTIGATION: BD DID NOT RECEIVE SAMPLES OR PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THEREFORE, 20 RETAINED SAMPLES WERE FUNCTIONALLY TESTED AND THE CUSTOMER'S INDICATED FAILURE MODE OF UNDERFILL WAS NOT OBSERVED AS ALL 20 TUBES DREW WITHIN SPECIFICATION. BD WAS UNABLE TO CONFIRM CUSTOMERS INDICATED FAILURE MODE BASED ON THE RETAINED SAMPLES TEST RESULTS. NO DEFINITIVE ROOT CAUSE COULD BE ESTABLISHED FOR THE REPORTED DEFECT. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE CIT PLH 13X75 2.7 109 USI L-MG CE, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: SOME TUBES OF THIS LOT NUMBER DID NOT FILL PROPERLY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD BD TUBE CIT PLH 13X75 2.7 109 USI L-MG CE, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED 5 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: SOME TUBES OF THIS LOT NUMBER DID NOT FILL PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2406084 BD TUBE CIT PLH 13X75 2.7 109 USI L-MG CE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1202068

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown