BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EXTENSION SET

    MDR report key: 18674929 · Received February 9, 2024

    Report

    Report Number
    9616066-2024-00211
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    January 23, 2024
    Report Date
    April 5, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403471155
    PMA / PMN Number
    K171957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE CUSTOMER THAT THE EXTENSION SET AT THE T-PORT CONNECTION WAS LEAKING BLOOD DURING ASPIRATING. ONE PHOTO OF MATERIAL NUMBER MZXT5307 WAS SUBMITTED FOR QUALITY INVESTIGATION. EVALUATION OF THE PHOTO SHOWS AN EXTENSION SET WITHIN A PLASTIC BAG. THE PHOTO DOES NOT SHOW THE REPORTED LEAKAGE. THE CUSTOMER COMPLAINT OF LEAKAGE COULD NOT BE CONFIRMED. DUE TO NO PHYSICAL SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW FOR MODEL MZXT5307 LOT NUMBER 23119255 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 22NOV2023. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EXTENSION SET WAS LEAKING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: CUSTOMER SHARED THAT THE EXTENSION SET AT THE T-PORT CONNECTION WAS LEAKING BLOOD DURING ASPIRATING. OR IT WOULD LEAK SALINE. CUSTOMER SAID THIS HAS HAPPENED ON 8 EXTENSION SETS OPENED BY NURSES IN THE ED.

    Description of Event or Problem · 0

    MATERIAL#: MZXT5307 BATCH#23119255. IT WAS REPORTED BY CUSTOMER THAT CUSTOMER SHARED THAT THE EXTENSION SET AT THE T-PORT CONNECTION WAS LEAKING BLOOD DURING ASPIRATING. OR IT WOULD LEAK SALINE. CUSTOMER SAID THIS HAS HAPPENED ON 8 EXTENSION SETS OPENED BY NURSES IN THE ED. VERBATIM: CUSTOMER SHARED THAT THE EXTENSION SET AT THE T-PORT CONNECTION WAS LEAKING BLOOD DURING ASPIRATING. OR IT WOULD LEAK SALINE. CUSTOMER SAID THIS HAS HAPPENED ON 8 EXTENSION SETS OPENED BY NURSES IN THE ED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378352 BD EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 23119255 10885403471155

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown