BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME

    MDR report key: 6968357 · Received October 23, 2017

    Report

    Report Number
    3009211636-2017-05331
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    September 29, 2017
    Report Date
    November 8, 2017
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    NFK
    UDI-DI
    10884521135543
    PMA / PMN Number
    K092205
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT 8888541123, HEMODIALYSIS CATHETER REPAIR KIT, WAS UTILIZED TO REPAIR THE CATHETER ASSOCIATED WITH THE EVENT REPORTED UNDER REPORT NUMBER 3009211636-2017-05330. THERE WAS NO PRODUCT FAILURE ASSOCIATED WITH THE ITEM 8888541123 AND THEREFORE THERE WILL BE NO ADDITIONAL SUPPLEMENTAL REPORTS SUBMITTED FOR THIS ITEM. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, ON (B)(6) 2017, DURING HEMODIALYSIS THE DEVICE¿S ARTERIAL LUER ADAPTER BECAME DETACHED FROM THE(BIONIC) EXTENSION LINES. THE LUER ADAPTER HAD TO BE RECONNECTED ON THE ARTERIAL LINE. IT WAS SUSPECTED THAT THE PATIENT WAS DISCONNECTING THE ARTERIAL LINES. NO PATIENT INJURY.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, ON (B)(6), DURING HEMODIALYSIS THE DEVICE¿S ARTERIAL LUER ADAPTER BECAME DETACHED FROM THE(BIONIC) EXTENSION LINES. THE LUER ADAPTER HAD TO BE RECONNECTED ON THE ARTERIAL LINE. IT WAS SUSPECTED THAT THE PATIENT WAS DISCONNECTING THE ARTERIAL LINES. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747990 PALINDROME KIT, REPAIR, CATHETER, HEMODIALYSIS NFK COVIDIEN MFG SOLUTIONS S.A. 8888541123 1428800041 10884521135543

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR