BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOCATH-T 26G

    MDR report key: 3529362 · Received September 11, 2013

    Report

    Report Number
    3005515211-2013-00011
    Event Type
    Malfunction
    Date Received
    September 11, 2013
    Date of Event
    January 1, 2013
    Report Date
    August 12, 2013
    Manufacturer
    AMSINO MEDICAL CO., LTD.
    Product Code
    FOZ
    PMA / PMN Number
    PREAMEN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FOZ. AND THE INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK. ON AN UNSPECIFIED DATE, THE CATHETER WAS TO BE USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE. THE CUSTOMER CONTACT REPORTED THAT WHEN THE CATHETER WAS CONNECTED TO AN UNSPECIFIED TUBING SET, AN UNSPECIFIED VOLUME OF SOLUTION LEAKED. IT WAS REPORTED THAT THE DEVICE DID NOT APPEAR TO BE SEALING EFFICIENTLY WHEN CONNECTED TO THE LINE. NO SPECIFIC DETAILS WERE PROVIDED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED INCLUDING IF THE TUBING SET WAS REPLACED AND THERAPY WAS INITIATED. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457794 ABBOCATH-T 26G 80FOZ FOZ AMSINO MEDICAL CO., LTD. NA 26201KY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA