BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIODYNAMICS / BIOFLO

    MDR report key: 6131424 · Received November 29, 2016

    Report

    Report Number
    1317056-2016-00176
    Event Type
    Malfunction
    Date Received
    November 29, 2016
    Date of Event
    November 1, 2016
    Report Date
    November 2, 2016
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJS
    UDI-DI
    H965458320
    PMA / PMN Number
    K121089
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE IT HAS BEEN INDICATED THAT THE DEVICE FROM THE REPORTED EVENT WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION, IT HAS NOT YET ARRIVED. UPON RECEIPT OF THE SAMPLE / COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4) NOT YET RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    ANGIODYNAMICS HAS BEEN INFORMED BY THE ORIGINAL EVENT REPORTER THAT THIS COMPLAINT IS A DUPLICATE OF ANOTHER COMPLAINT THEY REPORTED. THE OTHER COMPLAINT (ANGIODYNAMICS COMPLAINT #(B)(4)) HAS BEEN INVESTIGATED AND REPORTED TO THE FDA ON MEDWATCH 1317056-2017-00003. THIS COMPLAINT, REPRESENTED BY MEDWATCH 1317056-2016-00176, IS THEREFORE BEING CANCELLED IN ANGIODYNAMICS' COMPLAINT SYSTEM. ((B)(4))

    Description of Event or Problem · 1

    AS REPORTED BY ANGIODYNAMICS' DISTRIBUTOR IN THE (B)(6), " LUMEN OF A 5FR. BIOFLO PICC THROUGH WHICH PARENTERAL NUTRITION WAS BEING DELIVERED CRACKED ON DAY 19 OF USE." THE DEVICE WAS REMOVED AND REPLACED. IT HAS BEEN INDICATED THAT THE USED CATHETER WILL BE RETURNED TO ANGIODYNAMICS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782796 ANGIODYNAMICS / BIOFLO PERIPHERALLY INSERTED CENTRAL CATHETER LJS ANGIODYNAMICS H965458320 5014842 H965458320

    Patients

    Seq Age Sex Outcome Treatment
    1