BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 21160759 · Received January 15, 2025

    Report

    Report Number
    9616066-2024-02269
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Date of Event
    December 16, 2024
    Report Date
    March 11, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403238345
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    SEVEN 2000E SAMPLES WERE RECEIVED FOR INVESTIGATION OF (B)(4). NO PACKAGING WAS RECEIVED WITH ANY OF THE SAMPLES, AND THE CUSTOMER HAS ONLY PROVIDED A PARTIAL LOT NUMBER (240227). NO SAMPLE OF THE CONNECTING PRODUCT WAS RECEIVED TO AID THE INVESTIGATION. THE CUSTOMER REPORTED: "THE HEAD NURSE OF THE INFECTIOUS DISEASES DEPARTMENT REPORTED THAT THERE WAS A BLOCKAGE DURING THE USE OF THE PRODUCT, AND THE LIQUID MEDICINE COULD NOT PASS THROUGH." THE RETURNED SAMPLES WERE SUBJECTED TO FUNCTIONAL TESTING BY PRIMING AND FLUSHING USING A 50ML BD PLASTIPAK SYRINGE. OF THE SEVEN SAMPLES PROVIDED, FIVE WERE FLUSHED SUCCESSFULLY, WITH NO FLOW RESTRICTION ENCOUNTERED; HOWEVER, TWO WERE FOUND TO BE COMPLETELY OCCLUDED. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. FOLLOWING A SMALL NUMBER OF SIMILAR REPORTS, BD HAS CONDUCTED AN IN-DEPTH INVESTIGATION TO IDENTIFY ANY POTENTIAL CONTRIBUTING FACTORS FOR OCCLUSION AT THE SMARTSITE OF THIS NATURE. THE INVESTIGATION HAS DETERMINED THAT A POTENTIAL CONTRIBUTOR COULD BE THE RESULT OF AN INSUFFICIENT AMOUNT OF FLUOROSILICONE HAVING BEEN INJECTED INTO THE PISTON OF THE SMARTSITE DURING THE ASSEMBLY PROCESS; FLUOROSILICONE IS USED AS A LUBRICANT WITHIN THE SMARTSITE TO ENSURE THE CONSISTENT OPENING OF THE PISTON WHEN THE SMARTSITE IS ACTIVATED, AND AN INSUFFICIENT AMOUNT MAY CAUSE A TEMPORARY OCCLUSION. THEY CONFIRMED THAT THE INCORRECT AMOUNT OF FLUOROSILICONE WAS LIKELY DUE TO A FAULT WITHIN THE ASSEMBLY MACHINE DURING MANUFACTURE OF THE AFFECTED SMARTSITE. ONLY A PARTIAL LOT NUMBER WAS PROVIDED AS PART OF THE INVESTIGATION; HOWEVER A REVIEW OF THE LASER ID FROM THE SMARTSITE COMPONENT CONFIRMED THE LIKELY LOT NUMBER TO BE 24026417. A REVIEW OF THE PRODUCTION RECORDS FOR THE POTENTIAL LOT DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. SINCE THE MANUFACTURE OF THE REPORTED LOT, THE AUTOMATIC ASSEMBLY MACHINE HAS BEEN REPAIRED TO ENSURE THE FLUOROSILICONE IS BEING CORRECTLY DISPENSED INTO EACH SMARTSITE; FURTHERMORE AT THE START OF THE ASSEMBLY PROCESS THE MANUFACTURING OPERATIVE WILL CONTINUE TO MEASURE WHETHER A SUFFICIENT AMOUNT OF FLUOROSILICONE IS BEING INJECTED. THE QUALITY TEAM AT THE MANUFACTURING SITE HAS BEEN INFORMED OF THIS REPORT AND WILL CONTINUE TO MONITOR THE INCOMING FEEDBACK AND REMAIN VIGILANT TO ISSUES OF THIS NATURE DURING FUTURE PRODUCTION. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT REPORTS OF THIS NATURE AGAINST PRODUCTS IN THE SMARTSITE PRODUCT FAMILY ARE RARE AND HAVE BEEN OCCURRING AT A LOW FREQUENCY WITHIN THE LAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS SMARTSITE NEEDLE-FREE VALVE WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM THE HEAD NURSE OF THE INFECTIOUS DISEASES DEPARTMENT REPORTED THAT THERE WAS A BLOCKAGE DURING THE USE OF THE PRODUCT, AND THE LIQUID MEDICINE COULD NOT PASS THROUGH. THE NUMBER OF AFFECTED PRODUCTS WAS 15, AND 8 SAMPLES COULD BE RETURNED. PHOTOS ARE AVAILABLE. A GREEN CLAIM SETTLEMENT IS REQUIRED, AS WELL AS A COMPLAINT RESPONSE LETTER AND A COMPLAINT ACCEPTANCE LETTER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274817 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. 24026417 10885403238345

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown