BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET

    MDR report key: 9131297 · Received September 27, 2019

    Report

    Report Number
    1416980-2019-05295
    Event Type
    Malfunction
    Date Received
    September 27, 2019
    Date of Event
    September 3, 2019
    Report Date
    October 31, 2019
    Manufacturer
    BAXTER HEALTHCARE - CARTAGO
    Product Code
    FPA
    UDI-DI
    00085412071107
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION : CORRECTION: CHANGE THE DEVICE QUANTITY TO AN UNSPECIFIED NUMBER OF CLEARLINK SYSTEM CONTINU-FLO SOLUTION SETS. CORRECTION: COMBINE THE RESULTS OF THE SAMPLE EVALUATION INTO ONE REPORT AS A SAMPLE WAS RECEIVED FOR EVALUATION, HOWEVER, THE ISSUE OF DAMAGED SEPTUM COULD NOT BE VERIFIED BECAUSE THE CLEARLINK COMPONENT DOES NOT HAVE A SEPTUM AND ALL RELEVANT EVALUATION INFORMATION RELATED TO THIS EVENT IS CONTAINED IN THE FOLLOW UP MEDICAL DEVICE REPORT, MANUFACTURING REPORT # 1416980-2019-05296. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    MFR ADDRESS: 600 MTS. OESTE DE ENTRADA, PRINCIPAL AVE. LAS AMERICAS, PARQUE INDUSTRIAL. THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET HAD A DAMAGE SEPTUM. THE REPORTER STATED THAT "IT BEHAVED AS THOUGH A NEEDLE WAS STUCK INTO THE SITE"; HOWEVER, THE CUSTOMER ASSURED THAT THERE WAS NO NEEDLE STUCK IN THE SEPTUM. THIS ISSUE WAS IDENTIFIED DURING PATIENT USE. 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
    923272 CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - CARTAGO NA R19F20111 00085412071107

    Patients

    Seq Age Sex Outcome Treatment
    1