BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    18 CM (7") PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR, ROTATING LUE

    MDR report key: 14780343 · Received June 22, 2022

    Report

    Report Number
    9617594-2022-00185
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    May 4, 2022
    Report Date
    June 13, 2022
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619081591
    PMA / PMN Number
    K100576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: THIS IS THE DATE THE DEVICE WAS RETURNED TO ICU MEDICAL, INC FOR EVALUATION. DATE OF REPORT: THIS IS THE DATE ICU MEDICAL, INC ENGINEERING SIGNED OFF ON THE COMPLETED EVALUATION. DESCRIBE EVENT OR PROBLEM: SEE SECTION DESCRIBE EVENT OR PROBLEM FOR INFORMATION REGARDING HOW INCIDENT BECAME KNOWN TO ICU MEDICAL, INC. USAGE OF DEVICE: THE DEVICE WAS OPENED BUT UNUSED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED A SEPARATED PRESSURE TUBING TO ICU MEDICAL INC AND AN INITIAL EMDR WAS SUBMITTED BY THE MANUFACTURER UNDER MFR REPORT REF #9617594-2022-00081-00. THE CUSTOMER RETURNED THE ORIGINAL DEVICE FOR EVALUATION, BUT ALSO RETURNED AN ADDITIONAL OPEN/UNUSED DEVICE 18 CM (7") PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE CLEAR, ROTATING LUER FOR EVALUATION ON (B)(6) 2022. A PULL TEST WAS PERFORMED ON THE REPRESENTATIVE TUBING/MALE LUER ADAPTOR BOND OF THE UNUSED SAMPLE AND IT FAILED. SOME SOLVENT WAS PRESENT ON THE TUBING. NO OTHER DAMAGE OR ANOMALIES WERE IDENTIFIED. THE SAMPLE FAILED TO MEET THE BOND INTEGRITY REQUIREMENTS. THE PROBABLE CAUSE IS DUE TO A BONDING ERROR DURING MANUFACTURING. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1401560 18 CM (7") PRESSURE INFUSION (400PSIG) EXT SET W/MICROCLAVE® CLEAR, ROTATING LUE SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5800251 00840619081591

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown