BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SMARTSITE¿ NEEDLE-FREE VALVE

    MDR report key: 15601252 · Received October 13, 2022

    Report

    Report Number
    9616066-2022-01539
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    September 20, 2022
    Report Date
    October 27, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 17-NOV-2022. INVESTIGATION SUMMARY : ONE 2000E7D SAMPLE FROM LOT 1022883 WAS RECEIVED IN SEALED PACKAGING FOR INVESTIGATION IN WHICH THE CUSTOMER HAS REPORTED EXPERIENCING DIFFICULTY SEPARATING THE SMARTSITE PRODUCT FROM AN UNKNOWN CATHETER. NO SAMPLE OF THE CATHETER PRODUCT WAS RECEIVED TO AID THE INVESTIGATION. FURTHER DETAILS RELATING TO THE NATURE OF THE REPORTED ISSUE AND THE CLINICAL SET UP, INCLUDING DETAILS OF THE CATHETER PRODUCT TO WHICH THE 2000E7D PRODUCT WAS CONNECTED, WERE NOT PROVIDED TO AID THE INVESTIGATION. THE CUSTOMER DID PROVIDE TWO PHOTOGRAPHS, HOWEVER, THESE ONLY SHOW A SIDE VIEW OF THE SMARTSITE COMPONENT AND ITS ASSOCIATED PACKAGING. EXAMINATION OF THE SAMPLE FOUND NO DAMAGE OR DEFORMITY WHICH MIGHT EXPLAIN THE CUSTOMER'S EXPERIENCE. IN ORDER TO TRY TO REPLICATE THE ISSUE REPORTED BY THE CUSTOMER, THE 2000E7D SAMPLE WAS CONNECTED TO VARIOUS OTHER PRODUCTS FROM BD STOCK; NO CONNECTION ISSUES WERE ENCOUNTERED, IN EACH INSTANCE THE CONNECTION BETWEEN THE PRODUCTS WAS SECURE, BUT IT WAS ALSO POSSIBLE TO SEPARATE THE PRODUCTS WHEN REQUIRED. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION, WHERE A REVIEW OF THE PRODUCTION RECORDS FOR LOT 1022883 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE CAUSED OR CONTRIBUTED TO A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED IN THIS INSTANCE AS NO DEFECTIVE PRODUCTS WERE PROVIDED FOR EXAMINATION AND TESTING OF THE RETURNED UNUSED SAMPLE DID NOT IDENTIFY ANY PRODUCT DEFECTS THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER NAME AND ADDRESS: FIRST NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿ NEEDLE-FREE VALVE EXPERIENCED DIFFICULT DISCONNECTION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGESE: WHEN USED FOR THE ADMINISTRATION OF INDOVENOUS MEDICINES, IN WHICH A SIMPLE EQUIPMENT OR INFUSION PUMP EQUIPMENT IS USED, WHEN DISCONNECTING FROM THE DEVICE, IT PRESENTS PRESSURE WHICH PREVENTS IT FROM BEING REMOVED. IT IS NECESSARY TO DISCONNECT THE CATHETER SEALING DEVICE TO ATTEMPT TO REMOVE IT, WHICH ENDS "OPENING" THE SYSTEM, WHICH CAN OCCUR BLOOD CHAIN INFECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SMARTSITE¿¢ NEEDLE-FREE VALVE EXPERIENCED DIFFICULT DISCONNECTION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGESE: WHEN USED FOR THE ADMINISTRATION OF INDOVENOUS MEDICINES, IN WHICH A SIMPLE EQUIPMENT OR INFUSION PUMP EQUIPMENT IS USED, WHEN DISCONNECTING FROM THE DEVICE, IT PRESENTS PRESSURE WHICH PREVENTS IT FROM BEING REMOVED. IT IS NECESSARY TO DISCONNECT THE CATHETER SEALING DEVICE TO ATTEMPT TO REMOVE IT, WHICH ENDS "OPENING" THE SYSTEM, WHICH CAN OCCUR BLOOD CHAIN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889170 BD SMARTSITE¿ NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 1022883

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown