BEUDAMED
    FDA Adverse Event Injury Summary report: N

    129" (328 CM) APPX 16.4 ML, 15 DROP PRIMARY SET W/BCV-CLAVE®, CLAVE®, REMV 4-WAY

    MDR report key: 19584424 · Received June 21, 2024

    Report

    Report Number
    9617594-2024-00791
    Event Type
    Injury
    Date Received
    June 21, 2024
    Date of Event
    May 1, 2024
    Report Date
    August 7, 2024
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00887709034082
    PMA / PMN Number
    K974589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT OF CRACKS ON ITEM Z3626 CANNOT BE CONFIRMED. SINCE NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND PROBABLE CAUSE CANNOT BE DETERMINED. LOT HISTORY REVIEW WAS REVIEWED, AND NO NON-CONFORMITIES WERE FOUND THAT WOULD HAVE LED TO THE REPORTED CONDITION ON THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION, HOWEVER, IT IS NOT YET RECEIVED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A 129" (328 CM) APPX 16.6 ML, 15 DROP PRIMARY SET W/2 CLAVE¿, REMV 4-WAY STOPCOCK W/CLAVE¿, SPIN LUER, 2 EXT WHERE THE CUSTOMER REPORTED THAT THE TUBING IS POOR QUALITY AND HAVE BEEN CRACKING AND LEAKING WHEN IN USE. THERE WAS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.AND UNKNOWN HARM. ILAPITAN 28-MAY-2024. GCM RECEIVED AN EMAIL ON 24-MAY-2024 FROM DAVID REYES, COMPLAINT COORD I OF MEDLINE INDUSTRIES, LP WITH REGARD TO A 129" (328 CM) APPX 16.6 ML, 15 DROP PRIMARY SET W/2 CLAVE¿, REMV 4-WAY STOPCOCK W/CLAVE¿, SPIN LUER, 2 EXT WITH ITEM NUMBER Z3626 AND LOT NUMBER 13875905. IT WAS REPORTED THAT THE CUSTOMER HAS RECEIVED TUBES THAT ARE POOR QUALITY. THE TUBES HAVE BEEN CRACKING AND LEAKING WHEN IN USE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HARM. ILAPITAN 28-MAY-2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284875 129" (328 CM) APPX 16.4 ML, 15 DROP PRIMARY SET W/BCV-CLAVE®, CLAVE®, REMV 4-WAY SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13875905 00887709034082

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown