BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9" SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER

    MDR report key: 18682172 · Received February 9, 2024

    Report

    Report Number
    9617594-2024-00135
    Event Type
    Malfunction
    Date Received
    February 9, 2024
    Date of Event
    July 1, 2023
    Report Date
    May 4, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00(01)(17)(10)
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF THE LEAK WAS NOT CONFIRMED ON THE RETURNED SET. IMAGES WERE PROVIDED BY THE CUSTOMER SHOWING THE INVOLVED DEVICES. NO VISUAL ANOMALIES WERE OBSERVED ON THE RETURNED TWO (2) SETS. BOTH THE RETURNED SETS WERE PRIMED AND PRESSURE LEAK TESTED AND NO LEAKS WERE OBSERVED. THE CLAVES WERE DISASSEMBLED TO CHECK FOR A LEAK AND NO ANOMALIES WERE OBSERVED WHICH WOULD LEAD TO A LEAK. THE PRODUCT HAD PERFORMED PER THE SPECIFICATIONS. A DEVICE HISTORY REVIEW (DHR) COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED. D9 DATE RETURNED TO MFG: 2/14/2024. ADDITIONAL INFORMATION IN D1, D2A, D2B, D4, G4.

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. WITHOUT THE RETURNED DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, ON AN UNKNOWN DATE IN JULY, A SET EXT 9¿ W/CLAVE & 2 CLAMPS NON-DEH GENERATED A LEAK DURING USE ON A PATIENT. AS PER THE REPORT, LEAKING WAS NOTED DURING THE FLUSHING OF THE ATTACHED INFUSION DEVICE. THE PRODUCT WAS USED FOR LESS THAN 4 DAYS. MEDICAL INTERVENTION WAS REQUIRED- REQUIRED INTRAVENOUS (IV) LINE TO BE OPENED AND THE DEVICE REPLACED, INCREASING THE RISK OF BLOODSTREAM INFECTION. THE PROBLEM WAS DISCOVERED BY THE REGISTERED NURSE (RN) DURING ATTEMPTED FLUID ADMINISTRATION. THE SEVERITY OF THE COMPLAINT WAS INCONVENIENCE OR TEMPORARY DISCOMFORT. THE CATEGORY OF THE PROBLEM WAS PRODUCT PERFORMANCE. THERE WERE NO UNUSUAL CIRCUMSTANCES. INTUBATION WAS NOT NECESSARY. THE DEVICE WAS NOT RE-STERILIZED OR RE-PROCESSED. THE DEVICE WAS PRE-TESTED BEFORE USE. A SECOND DEVICE IS REQUIRED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378801 9" SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN 00(01)(17)(10)
    887235 9" SMALLBORE EXT SET W/CLAVE®, CLAMPS, ROTATING LUER STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN 00(01)(17)(10)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown