BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRESCENT JUGULAR DUAL LUMEN CATHETER 30 FR

    MDR report key: 14604957 · Received June 6, 2022

    Report

    Report Number
    3011468686-2022-00008
    Event Type
    Injury
    Date Received
    June 6, 2022
    Date of Event
    March 17, 2022
    Report Date
    June 6, 2022
    Manufacturer
    MC3 INC.
    Product Code
    PZS
    UDI-DI
    1085496006819
    PMA / PMN Number
    K180151
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A LOT NUMBER WAS NOT PROVIDED. THE COMPALINT OF A CRACK WAS CONFIRMED BY INFORMATION PROVIDED BY THE CUSTOMER. REVIEW OF THE INFORMATION PROVIDED BY THE CUSTUMER CONCLUDES THAT THE CRACK WAS LIKELY CAUSED BY FATIGUE ASSOCIATED WITH CATHETER ECMO USE FOR 188 DAYS. ALSO, INADEQUATE SECUREMENT CANNOT BE RULED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT FOR ADDITIONAL INFORMATION IN B1(ADVERSE EVENT), B2 (REQUIRED INTERVENTION...), D4 (ADDED LOT # AND EXPIRATION DATE). CORRECTION TO D4 (UDI), D9 (DEVICE IS NOT AVAILABLE FOR EVALUATION), G1 (CONTACT INFORMATION), AND H1 (CHANGE FROM MALFUNCTION TO SERIOUS INJURY).

    Description of Event or Problem · 0

    DISTRIBUTOR REPORTED THAT THEY RECIEVED INFORMATION FROM A CUSTOMER WHO DESCRIBED THAT DURING USE OF A MC3 CRESCENT CATHETER (30 F) THAT A PORTION OF THE WIRE REINFORMCEMNT SECTION CRACKED WHICH INTRODUCED AIR INTO THE CATHETER. THE CATHETER WAS REMOVED AND THE DEVICE WAS REPLACED ON (B)(6) 2022. THERE WAS NO PATIENT IMPACT. THE CUSTOMER STATED THAT THE INITIAL PLACEMENT OF THE CATHETER INTO THE RIGHT INTERNAL JUGULAR WAS PERFORMED ON (B)(6) 2021 AT (B)(6) MEDICAL CENTER. THE PATIENT WAS TRANSFERED TO (B)(6) CENTER ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185635 CRESCENT JUGULAR DUAL LUMEN CATHETER 30 FR DUAL LUMEN ECMO CANNULA PZS MC3 INC. 70130 2101199 1085496006819

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention