BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOCATH-T 20G 1-1/4IN

    MDR report key: 3873766 · Received April 4, 2014

    Report

    Report Number
    3005515211-2014-00006
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    AMSINO MEDICAL (SHANGHAI) CO., LTD.
    Product Code
    FOZ
    PMA / PMN Number
    PREAMEN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACT INDICATED THAT THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT COMPLETE. 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 DEVICE BREAKAGE. AT AN UNSPECIFIED TIME, IT WAS REPORTED THAT THE DEVICE WAS INSERTED FOR AN UNSPECIFIED LOCATION OF THE PATIENT FOR AN UNSPECIFIED REASON. IT WAS REPORTED THE CATHETER SHEATH BROKE UPON ENTRANCE CAUSING PAIN TO THE PATIENT. THE DEVICE WAS WITHDRAWN FROM THE PATIENT. NO SPECIFIC DETAILS WERE PROVIDED. THE DEVICE WAS REPLACED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAY OF THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204648 ABBOCATH-T 20G 1-1/4IN 80FOZ FOZ AMSINO MEDICAL (SHANGHAI) CO., LTD. NA 23204KY

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK