BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IV ADMIN SET, 15DRP, 3 NF PORTS, 112"

    MDR report key: 13725130 · Received March 10, 2022

    Report

    Report Number
    1417592-2022-00026
    Event Type
    Injury
    Date Received
    March 10, 2022
    Date of Event
    February 1, 2022
    Report Date
    March 10, 2022
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY THE FACILITY THAT THE ROLLER CLAMP ON THE TUBING IS NOT FUNCTIONING PROPERLY AND THE INJECTION PORT IS LEAKING. ACCORDING TO THE FACILITY THE PATIENTS ARE RECEIVING FLUID BOLUSES AS WELL AS ADDITIONAL MEDICATION/SEDATION. PER THE FACILITY THE TUBING IS BEING USED TO ADMINISTER FLUIDS, MEDICATIONS, AND CONTRAST AT AN ENDOSCOPY AND PAIN DEPARTMENT. ACCORDING TO THE FACILITY, THE DATE, AND NUMBER OF PATIENTS IS UNDETERMINED. THE FACILITY STATED THAT THE ROLLER CLAMP WAS ALLOWING THE INFUSION TO INFUSE TOO QUICKLY REPORTING THAT BETWEEN 200CC AND 500CC'S OF 0.9% NORMAL SALINE SOLUTION WOULD BE INFUSED OVER A 10 MINUTE PERIOD WHEN THE CLAMP WAS SECURED. THE FACILITY STATED THAT THE INTRAVENOUS SITE WAS PLACED APPROXIMATELY 30 MINUTES PRIOR TO THE PROCEDURE AND WAS REMOVED APPROXIMATELY ONE HOUR AFTER THE PROCEDURE. REPORTEDLY, AN UNKNOWN NUMBER OF PATIENTS UNDERWENT PAIN PROCEDURES WHERE THEY WERE ADMINISTERING FENTANYL AND VERSED. THE FACILITY STATED THAT DURING ONE INCIDENT THERE WAS A POOL OF FLUID ON THE PROCEDURE TABLE AT THE AREA OF THE INSERTION PORT HUB. THE CLINICIAN NOTED APPROXIMATELY 20CC OF FLUID ON THE PROCEDURE TABLE WHERE THE INJECTED MEDICATION PORT WAS LOCATED. THE PATIENT NEEDED MORE MEDICATION AS THEIR MEDICATION LEAKED OUT OF THE TUBING AT THE PORT SITE. IT WAS NOT KNOWN HOW MUCH MEDICATION WAS ACTUALLY INFUSED. THERE WAS NO REPORT OF ANY ADVERSE PATIENT CONSEQUENCE, NO EFFECT ON THE PATIENT'S STABILITY, AND NO MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE INCIDENT. A SAMPLE WAS RETURNED TO THE MANUFACTURER AND THE CUSTOMER REPORTED ISSUE COULD NOT BE CONFIRMED. THE DEVICE PASSED ALL VISUAL, FUNCTIONAL AND DIMENSIONAL SPECIFICATIONS AND TESTING. ACCORDING TO THE FACILITY THE DEVICES ROLLER CLAMPS ARE LEFT IN HALF CLAMP POSITIONS WHICH DOES NOT GUARANTEE FLOW ROW AND THE DEVICES ARE USED ALONGSIDE AN INFUSION PUMP TO ADMINISTER FLUIDS WHICH IS NOT NOTED TO BE COMPATIBLE WITH THIS FLUID SET THEREFORE THE ROOT CAUSE IS NOTED TO BE DUE TO USE ERROR. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE FACILITY THAT THE ROLLER CLAMP ON THE TUBING IS NOT FUNCTIONING PROPERLY AND THE INJECTION PORT IS LEAKING. ACCORDING TO THE FACILITY THE PATIENTS ARE RECEIVING FLUID BOLUSES AS WELL AS ADDITIONAL MEDICATION/SEDATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2117604 IV ADMIN SET, 15DRP, 3 NF PORTS, 112" FPA MEDLINE INDUSTRIES LP 0332110A048

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other