BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    41 CM (16") APPX 2.7ML, EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE, LUER CHECK

    MDR report key: 11255145 · Received January 29, 2021

    Report

    Report Number
    9617594-2021-00021
    Event Type
    Malfunction
    Date Received
    January 29, 2021
    Date of Event
    January 20, 2021
    Report Date
    January 20, 2021
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619007843
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DHR FOR LOT NUMBER 4960976 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE REPORTED COMPLAINT CANNOT BE CONFIRMED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED. ADDITIONAL INFORMATION CAN BE FOUND IN D9.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. A REPRESENTATIVE DEVICE FROM THE SAME LOT IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A 41 CM (16") APPX 2.7ML, EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE®, LUER CHECK VALVE THAT THE CUSTOMER REPORTED A LEAK OF AN UNSPECIFIED CHEMOTHERAPY DRUG ONTO THE NURSE'S FOREARM DURING CONNECTION TO A PATIENT AS RESULT OF THE CLAMP SPONTANEOUSLY UNCLAMPING FROM THE EXTENSION SET. PRIOR TO THE EVENT, THE EXTENSION WAS PRIMED AND CLAMPED BY THE PREPARERS IN THE PHARMACY. THE CUSTOMER REPORTED THAT THEIR PROCEDURES INSTRUCT THEM TO PRIME THE TUBING AND THEN CLAMP IT IN ORDER TO BE ABLE TO CHANGE THE CAP. THE CUSTOMER REPORTED THEY HAVE IMPLEMENTED CORRECTIVE ACTIONS WHERE THE PHARMACY TEAM SYSTEMATICALLY CHECKS THE CLAMPING BEFORE RELEASE AND THE NURSES MUST CHECK THE CLAMPING PRIOR TO OPENING THE BAG THAT CONTAINS THE INFUSION BAG. THE DEVICE WAS NOT REPLACED AND NO FURTHER PROBLEM ENCOUNTERED. THERE WAS PATIENT INVOLVEMENT AND ALTHOUGH THERE WAS A REPORT OF UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE NURSE, THERE WAS NO HARM REPORTED, NO SERIOUS INJURY, NO BLOOD LOSS, NO DELAY IN THERAPY, NO NEGATIVE CONSEQUENCES TO THE OPERATOR, NO CLINICAL CONSEQUENCE TO THE PATIENT, AND NO NEED FOR MEDICAL INTERVENTION. THIS CAPTURES THE SECOND OF THREE EVENTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151458 41 CM (16") APPX 2.7ML, EXT SET TUBING PUR AMBRATE, SPIKE, Y-CLAVE, LUER CHECK STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4960976 00840619007843

    Patients

    Seq Age Sex Outcome Treatment
    1 UNSPECIFIED CHEMOTHERAPY (MFR UNK)