BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED CENTRAL LINE CONNECTOR

    MDR report key: 22452005 · Received July 8, 2025

    Report

    Report Number
    9617594-2025-01426
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    January 1, 2025
    Report Date
    September 30, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 AND H4 THE LOT#, EXPIRATION DATE, AND MANUFACTURE DATE ARE UNKNOWN. D2 AND G4 - THE PRODUCT CODE, THE COMMON DEVICE NAME, AND 510 ARE UNKNOWN. K964435, STOPCOCK, I.V. SET, AND FMG, WERE USED AS PLACE HOLDERS. THE DEVICE HAS BEEN REQUESTED FOR EVALUATION- IT HAS NOT BEEN RECEIVED. THE INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9. DEVICE RECEIVED ON 7/31/2025. INVESTIGATION SUMMARY: RECEIVED ONE (1) USED. LIST # 011-MC3316, EXT SET, SMALLBORE BIFUSE W/2 CLAVE FOR INSPECTION. NO DAMAGE OR ANOMALIES WERE OBSERVED. THE SET WAS LEAK TESTED PER PRODUCT SPECIFICATIONS. THERE WAS LEAKAGE FROM THE MICROCLAVE. THE INTERNAL SEAL WAS FOUND TO HAVE EXCESSIVE TEARING THAT PROPAGATED TO THE SIDE WALL. THE REPORTED COMPLAINT OF LEAKAGE CAN BE CONFIRMED DUE TO THE TORN SEAL. THE PROBABLE CAUSE OF THE TORN SEAL IS DUE TO ACCESS WITH AN INCOMPATIBLE MATING DEVICE. THE DFU STATES: THE CLAVE / MICROCLAVE CONNECTOR IS COMPATIBLE WITH LUERS WITH AN INTERNAL DIAMETER (ID) BETWEEN 1.55 MM AND 2.8 MM. A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED REGARDING A UNSPECIFIED CENTRAL LINE CONNECTOR THAT EXPERIENCED CRACKING. THE REPORTER STATED THAT " CRACKED AND FAILED CENTRAL LINE CONNECTORS HAS BEEN REPORTED, WHICH IS SUSPECTED TO BE DUE TO A MANUFACTURING FAULT ¿. UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576993 UNSPECIFIED CENTRAL LINE CONNECTOR STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown