BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/18 IN

    MDR report key: 4182115 · Received April 8, 2014

    Report

    Report Number
    3004365956-2014-00159
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    TELEFLEX
    Product Code
    CAG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FIVE (5) PICTURES OF THE PRODUCT CATALOG NUMBER 780-07 (CIRCUIT, NEONATAL, DUAL HTD LIMB W/18 IN R) WERE RECEIVED FOR ANALYSIS. THEY WERE VISUALLY INSPECTED, IT CAN ONLY BE IDENTIFIED AS A SMALL RED CONTAMINATION RELATED WITH THE COMPLAINT, BUT IT IS HARD TO APPRECIATED THE CONTAMINATION TYPE WITHIN THE COMPONENT OF THE CIRCUIT. A DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) OF BATCH NUMBER (B)(4) HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND RELATED TO THIS COMPLAINT. NO NON-CONFORMANCE REPORTS WERE ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. THE DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. THIS CUSTOMER COMPLAINT CAN NOT BE CONFIRMED BASED ON THE RECEIVED PICTURES SINCE IT IS HARD TO APPRECIATED THE CONTAMINATION TYPE ON THE PRODUCT, TO PERFORM AN INVESTIGATION AND DETERMINE THE SOURCE OF DEFECT REPORTED IT IS NECESSARY TO EVALUATE THE SAMPLE INVOLVED IN THIS COMPLAINT. IF DEFECTIVE SAMPLE BECOMES AVAILABLE AT A LATER DATE THIS COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT A PIECE OF SMALL RED PLASTIC WAS FOUND INSIDE OF THE VENTILATOR CIRCUIT. THE ALLEGED DEFECT WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210483 HUDSON CIRCUIT, NEONATAL, DUAL HTD LIMB W/18 IN BREATHING CIRCUIT CAG TELEFLEX 02L1301102

    Patients

    Seq Age Sex Outcome Treatment
    1