BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE

    MDR report key: 22366233 · Received June 30, 2025

    Report

    Report Number
    9616066-2025-01781
    Event Type
    Malfunction
    Date Received
    June 30, 2025
    Date of Event
    June 6, 2025
    Report Date
    July 8, 2025
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A DE C.V.
    Product Code
    LHI
    UDI-DI
    07613203011792
    PMA / PMN Number
    K233021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. ADDRESS WAS NOT LOCATED AND (B)(6) WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF FLOW ISSUES - FLUID BLOCKAGE COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED ON MATERIAL 2203E BECAUSE THE LOT NUMBER IS UNKNOWN. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD 13 MM SS VIAL ACCESS DEVICE HAD FLOW ISSUES - FLUID BLOCKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 2203E, BATCH: UNKNOWN. THIS IS THE RECORD OPENED FOR "MANY OTHER PEOPLE" NO SAMPLE/SPECIFIC DETAILS FOR THIS RECORD! DESCRIPTION: CALLER CALLED ON BEHALF OF HER DAUGHTER TO REPORT BEING UNABLE TO PUSH THE WATER FROM A PREFILLED STERILE WATER SYRINGE IN THE WINREVAIR VIAL THAT IS DOCUMENTED IN PQC CASE#: (B)(4). DURING THE CALL, CALLER STATED THAT SHE "HEARD THAT THIS HAS BEEN AN ONGOING ISSUE WITH MANY OTHER PEOPLE TOO" (DOCUMENTED IN THIS PQC CASE: (B)(4) FOR THE MULTIPLE PATIENTS). NO PATIENT DEMOGRAPHICS WERE KNOWN BY REPORTER. PRECAUTIONARY AE IS FILED IN THIS CASE SINCE PATIENTS ARE INVOLVED. NO ADDITIONAL INFORMATION IS KNOWN BY REPORTER AND UNABLE TO OBTAINED. NO ADDITIONAL AE/NO ADDITIONAL PQC. DATE PQC OBSERVED: UNKNOWN BY REPORTER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1368081 BD ALARIS SMARTSITE SET, I.V. FLUID TRANSFER LHI SISTEMAS MEDICOS ALARIS S.A DE C.V. UNKNOWN 07613203011792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown