BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE®

    MDR report key: 11990043 · Received June 14, 2021

    Report

    Report Number
    2523676-2021-00176
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Report Date
    August 9, 2021
    Product Code
    FPA
    UDI-DI
    04046964298592
    PMA / PMN Number
    K083723
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT 2: THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). TWO (2) USED SAMPLES WERE PROVIDED FOR EVALUATION. ONE SAMPLE WAS LEAK TESTED PER INTERNAL SPECIFICATIONS WITH NO DEFECTS NOTED. THE OTHER SAMPLE WAS VISUALLY EVALUATED AND A VERTICAL CRACK WAS NOTED TO BE PRESENT ON THE M228 LUER LOCK CONNECTOR. BASED ON THE EVALUATION PERFORMED THE REPORTED DEFECT IS CONFIRMED AGAINST ONE SAMPLE. THE EXACT CAUSE COULD NOT BE DETERMINED AT THIS TIME. HOWEVER, INCIDENTS OF CRACKED/LEAKING CONNECTORS CAN POSSIBLY BE CAUSED BY SEVERAL FACTORS, INCLUDING BUT NOT LIMITED TO THE PRODUCT BEING SUBJECTED TO AGGRESSIVE SOLVENTS/DRUGS, EXCESSIVE MECHANICAL STRESSES (OVER-TIGHTENING OR FREQUENT SET MANIPULATION), OR OTHER VARIOUS UNFORESEEN CIRCUMSTANCES DURING THE CLINICAL APPLICATION. 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: EVENT 2: END USER REPORTS, "AFTER CONNECTING THE 3ML EMPTY NEEDLE (BD ECLIPSE 3ML), LEAKAGE OCCURRED WHEN THE NURSE PUSH THE MEDICINE." NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889424 CARESITE® SET, ADMINISTRATION, INTRA FPA 470103 0061768418 04046964298592

    Patients

    Seq Age Sex Outcome Treatment
    1