BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    40" (102 CM) APPX 5.3 ML ADMIN SET W/2 CHEMOLOCK¿

    MDR report key: 22206654 · Received June 13, 2025

    Report

    Report Number
    9615050-2025-00299
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 1, 2025
    Report Date
    October 16, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K131549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE AND SAMPLE PHOTOS ARE AVAILABLE SHOWING THE PRODUCT INVOLVED. THE UDI IS UNKNOWN AS ALL PRODUCT SPECIFIC INFORMATION WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    RECEIVED ONE (1) USED. LIST #011-CL3520, 40" (102 CM) APPX 5.3 ML ADMIN SET W/2 CHEMOLOCK¿, 20 DROP IN-LINE DRIP CHAMBER, BAG HANGER, DROP-IN CHEMOLOCK¿ PORT; LOT #14211833 CONNECTED TO ONE (1) USED PARTIAL. LIST #140019291, PRIMARY PLUM SET AND ONE (1) NEW. LIST #140019291, PRIMARY PLUM SET FOR EVALUATION. AS RECEIVED THE SECONDARY PORT CLAVE FROM A CASSETTE WAS BROKEN OFF AND STILL ATTACHED TO THE CHEMOLOCK. THE USED PLUM SET THAT THE PORT WAS BROKEN OFF FROM WAS NOT RETURNED. STRESS MARKS AND A RIGID BREAK WERE OBSERVED ON THE CLAVE. NO DAMAGE OR OTHER ANOMALIES WERE OBSERVED. THE COMPLAINT OF BROKEN B PORT CAN BE CONFIRMED ON THE ONE (1) USED PARTIAL SET DUE TO THE BROKEN B-PORT. THE PROBABLE CAUSE IS DUE TO AN UNINTENTIONAL BENDING FORCE. THE COMPLAINT OF BROKEN B-PORT COULD NOT BE REPLICATED OR CONFIRMED ON THE ONE (1) NEW SET.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION RECEIVED AND CORRECTED IN THIS REPORT IN THE FOLLOWING FIELDS: B5. D1 BRAND NAME - 40" (102 CM) APPX 5.3 ML ADMIN SET W/2 CHEMOLOCK¿, 20 DROP IN-LINE DRIP CHAMBER, BAG HANGER, DROP-IN CHEMOLOCK¿ PORT. D3 MANUFACTURING SITE. D4 & H4 - LOT#, MATERIAL#, EXPIRATION DATE. G4 - K131549. INVESTIGATION SUMMARY: RECEIVED (1) PHOTO SHOWING BROKEN B PORT, THE SHAPE OF THE DEFORMATION WAS ANGLED WHERE ONE SIDED IS HIGHER THAN THE OTHER, TYPICAL OF A BEND BREAK. THE REPORTED COMPLAINT OF A BROKEN CLAVE SECONDARY PORT CAN BE CONFIRMED. THE PROBABLE CAUSE OF THE BROKEN PORT IS DUE TO AN UNINTENTIONAL BENDING FORCE DURING USE.

    Description of Event or Problem · 0

    THE COMPLAINT INVOLVED A PLUM SET. IT WAS STATED THAT THE LINE B PORT SNAPPED OFF, IT HAPPENED ON A FILTERED LINE AND A NON-FILTERED LINE. CHEMOTHERAPY WAS BEING ADMINISTERED/PERFORMED. SAMPLE PHOTOS ARE AVAILABLE SHOWING THE PRODUCT INVOLVED. THERE WAS UNKNOWN PATIENT INVOLVEMENT, UNKNOWN DELAY IN THERAPY, AND UNKNOWN PATIENT HARMED.

    Description of Event or Problem · 0

    THE COMPLAINT INVOLVED A 40" (102 CM) APPX 5.3 ML ADMIN SET W/2 CHEMOLOCK¿, 20 DROP IN-LINE DRIP CHAMBER, BAG HANGER, DROP-IN CHEMOLOCK¿ PORT. IT WAS STATED THAT THE LINE B PORT SNAPPED OFF, IT HAPPENED ON A FILTERED LINE AND A NON-FILTERED LINE. CHEMOTHERAPY WAS BEING ADMINISTERED/PERFORMED. SAMPLE PHOTOS ARE AVAILABLE SHOWING THE PRODUCT INVOLVED. ADDITIONAL INFORMATION: ADDITIONAL SAMPLE PHOTOS WERE PROVIDED, SHOWING TWO DIFFERENT PRODUCTS, AN OPEN PACK OF LIST NUMBER 011-CL3520 LOT NUMBER 14211833 AND A SEALED PLUM SET WITH LIST NUMBER 14001 LOT NUMBER 14104055. IT WAS STATED THAT THE LOT NUMBER OF THE PRODUCT INVOLVED IS 14211833 WITH LIST NUMBER 011-CL3520.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635875 40" (102 CM) APPX 5.3 ML ADMIN SET W/2 CHEMOLOCK¿ SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14211833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED CHEMOTHERAPY, MFR UNK