BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE LOW SORBING EXTENSION SET

    MDR report key: 18531806 · Received January 17, 2024

    Report

    Report Number
    9616066-2024-00019
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    December 10, 2023
    Report Date
    February 13, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203012264
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE CUSTOMER REPORTED THAT THE TUBING IS KINKED. FOUR SAMPLES MODEL 20350E LOT 23059076 WERE RETURNED FOR INVESTIGATION. THE SETS WERE EXAMINED FOR DEFECTS AND ABNORMALITIES. ONE KINK WAS FOUND ON ONE SAMPLE JUST AFTER THE FILTER OUTLET. NO OTHER DEFECTS OR ABNORMALITIES WERE OBSERVED. THREE SETS WERE ATTACHED TO A 10 ML BD SYRINGE FILLED WITH WATER AND SUCCESSFULLY PRIMED. THE CUSTOMER COMPLAINT THAT THE TUBING WAS KINKED WAS VERIFIED BUT THIS DID NOT IMPEDE FLOW. FROM THE MANUFACTURER'S INVESTIGATION, THE POTENTIAL ROOT CAUSE OF KINKED TUBING COULD BE RELATED TO AN INCORRECT COILING OF THE PRODUCT, EXCESS OF SOLVENT AND AN INCOMPLETE INSERTION BETWEEN COMPONENTS BY THE ASSEMBLER. THE FAILURE MODE WAS ADDRESSED UNDER THE INVESTIGATION FOR THE PR 7043075. A QUALITY ALERT WAS GENERATED ON (B)(6) 2023 TO COMMUNICATE AND REINFORCE THE CORRECT ASSEMBLY PROCESS TO AVOID GAPS AND INCORRECT COILING. THE MEDICAL 15 BUSHING EVALUATION WAS CARRIED OUT TO REDUCE THE SOLVENT IN THE MEDICAL 15 SOLVENT DISPENSER ON (B)(6) 2023. THE EXPANDER SETUP WITH COMPRESSED AIR IN THE FIXTURES AREA WAS CARRIED OUT ON (B)(6) 2023. ADDITIONALLY, A WORK ORDER WAS CREATED AND COMPLETED ON (B)(6) 2023 TO ADDRESS ISSUES WITH THE MEDICAL SOLVENT DISPENSER. A DEVICE HISTORY RECORD REVIEW FOR MODEL 20350E LOT NUMBER 23059076 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 12MAY2023. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS SMARTSITE LOW SORBING EXTENSION SET WAS KINKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM TUBING IS KINKING AT THE FILTER. REPLACED SET AND TUBING KINKED AGAIN. THIS HAPPENED TWICE ON (B)(6) 2023 AND ONCE ON (B)(6) 2023 . ADDITIONAL NOTED IN EMAIL ATTACHED TO THIS PIR.

    Description of Event or Problem · 0

    NO ADDITIONAL INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653656 BD ALARIS SMARTSITE LOW SORBING EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 23059076 37613203012264

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown