BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUID DISPENSING CONNECTOR

    MDR report key: 11970446 · Received June 9, 2021

    Report

    Report Number
    2523676-2021-00165
    Event Type
    Malfunction
    Date Received
    June 9, 2021
    Report Date
    August 6, 2021
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    KYX
    UDI-DI
    04022495820105
    PMA / PMN Number
    K800437
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED FOR EVALUATION. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE.   REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION.   WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES.   IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT PARTICULATE MATTER WAS OBSERVED IN THE IMP-IV BAGS AFTER THE INFUSION WAS PREPARED. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868486 FLUID DISPENSING CONNECTOR DISPENSER, LIQUID MEDICATI KYX B. BRAUN MEDICAL INC. 415080 0061732516 04022495820105

    Patients

    Seq Age Sex Outcome Treatment
    1