BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD FEMALE LUER-LOK ADAPTER

    MDR report key: 13689372 · Received March 8, 2022

    Report

    Report Number
    9616066-2022-00205
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    March 3, 2022
    Report Date
    March 15, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A 1022-156-032 SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, HOWEVER THE CUSTOMER PROVIDED A PHOTOGRAPH OF THE AFFECTED COMPONENT; ANALYSIS OF THE PHOTOGRAPH CONFIRMED THE CUSTOMER'S EXPERIENCE AS THE PRODUCT APPEARED TO BE SLIGHTLY DISCOLOURED AND CLOUDY. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. PLEASE NOTE SINCE THE MANUFACTURE OF THE AFFECTED PRODUCT, THE SUPPLIER OF THIS COMPONENT HAS CHANGED TO AN ALTERNATIVE SUPPLIER, WHICH SHOULD ENSURE THAT REPORTS OF THIS NATURE ARE REDUCED IN FUTURE. THE SUPPLIER HAS BEEN NOTIFIED OF THE REPORTED ISSUE IN ORDER TO REDUCE THE LIKELIHOOD OF THE ISSUE OCCURRING DURING FUTURE PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD FEMALE LUER-LOK ADAPTER EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT CLOUDY - NOT TRANSPARENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD FEMALE LUER-LOK ADAPTER EXPERIENCED FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT CLOUDY - NOT TRANSPARENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670940 BD FEMALE LUER-LOK ADAPTER INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 0004025934

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown