BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOVAC

    MDR report key: 4231863 · Received October 16, 2014

    Report

    Report Number
    2952363-2014-00010
    Event Type
    Malfunction
    Date Received
    October 16, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ANGIODYNAMICS, INC.
    Product Code
    DWF
    PMA / PMN Number
    K091304
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING LOT (106711-2) FOR ITEM NUMBER VTX-3022 FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ANGIODYNAMICS COMPLAINT REPORT WAS REVIEWED FOR THE ANGIOVAC PRODUCT FAMILY FOR THE FAILURE MODE "TEAR IN POUCH.": NO ADVERSE TREND WAS IDENTIFIED. AS RECEIVED, THE RETURNED PRODUCT POUCH HAD A TEAR IN IT AS STATED BY THE COMPLAINT REPORTER. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AND THE RETURNED SAMPLE WERE SENT TO THE SUPPLIER, DUKE EMPIRICAL, FOR EVALUATION, ROOT CAUSE DETERMINATION, CORRECTIVE ACTION AND DHR REVIEW OF SUPPLIER LOT. DUKE EMPIRICAL INDICATED THAT THE DHR REVIEW REVEALED NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS NON-CONFORMANCE. A DEFINITIVE ROOT CAUSE AND THE ORIGIN OF THE TORN POUCH CANNOT BE DETERMINED. HOWEVER, THE TORN MYLAR IS MOST LIKELY A RESULT OF TRANSIT AND/OR HANDLING DAMAGE THAT OCCURRED AT SOME POINT BETWEEN THE SUPPLIER (DUKE), THE DISTRIBUTOR (STD) AND THE END USER HOSPITAL. THE DIRECTIONS FOR USE PROVIDED WITH THIS DEVICE CONTAINS THE FOLLOWING STATEMENT: "WARNING: DO NOT USE IF PRODUCT OR STERILE PACKAGING IS DAMAGED." (B)(4).

    Additional Manufacturer Narrative · 1

    THE PACKAGING FROM THE REPORTED EVENT IS BEING RETURNED TO ANGIODYNAMICS, BUT HAS NOT YET BEEN RECEIVED. UPON RECEIPT OF THE SAMPLE IT WILL BE FORWARDED TO OUR SUPPLIER, STD MED INC. ALONG WITH A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR). A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE PACKAGING OF THE ANGIOVAC CANNULA WAS TORN, THEREBY COMPROMISING THE STERILITY OF THE DEVICE. THE DEVICE WAS NOT USED AND THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656976 ANGIOVAC CATHETER, CANNULA & TUBING, VASCULAR DWF ANGIODYNAMICS, INC. NA 106711-2

    Patients

    Seq Age Sex Outcome Treatment
    1