BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3830970 · Received May 23, 2014

    Report

    Report Number
    1416980-2014-16882
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    March 21, 2014
    Report Date
    April 30, 2014
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS A TODDLER. (B)(6). THE SAMPLE IS REPORTED TO BE UNAVAILABLE FOR EVALUATION. IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE FOLLOWING: "THE CHILD DID NOT HAVE ANY EXTENSIONS ON THE LINE. THE TUBING WAS THROUGH A PUMP AS NORMAL THE CHILD ROLLED OVER TWICE WHILST ASLEEP AND THE TUBING WRAPPED AROUND HER NECK ." THE DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION COULD NOT BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BURETROL SOLUTION ADMINISTRATION SET WAS FOUND WRAPPED TWICE AROUND A PATIENT¿S NECK. THIS OCCURRED DURING PATIENT INFUSION OF UNSPECIFIED INTRAVENOUS FLUIDS. THE PATIENT WAS TUBING WAS THEN REMOVED AND THE PATIENT WAS ASSESSED; NO MARKS WERE LEFT AND THE PATIENT WAS BREATHING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307558 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS

    Patients

    Seq Age Sex Outcome Treatment
    1