BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOCATH-T 26 GA. COLOUR WHITE (500/CASE)

    MDR report key: 2624160 · Received May 24, 2012

    Report

    Report Number
    3005515211-2012-00002
    Event Type
    Injury
    Date Received
    May 24, 2012
    Date of Event
    April 21, 2012
    Report Date
    April 26, 2012
    Manufacturer
    AMSINO MEDICAL CO., LTD, CONTRACT MANUFACTURER FOR HOSPIRA INC.
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BE 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 IS PREAMENDMENT OF 510K. 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 THE CATHETER SHEARED. AT AN UNSPECIFIED DATE, THE CATHETER WAS SUCCESSFULLY INSERTED INTO THE PATIENT AT AN UNSPECIFIED LOCATION. ON (B)(6) 2012, AT AN UNSPECIFIED TIME, DURING REMOVAL OF THE CATHETER FROM THE PATIENT, IT WAS REPORTED THAT A PIECE OF THE CATHETER REMAINED LODGED IN THE PATIENT'S SKIN. THE CUSTOMER CONTACT REPORTED THAT A SURGEON WAS NOTIFIED AND THE PIECE OF CATHETER WAS REMOVED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOCATH-T 26 GA. COLOUR WHITE (500/CASE) UNK FOZ AMSINO MEDICAL CO., LTD, CONTRACT MANUFACTURER FOR HOSPIRA INC. NA 06204KY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention