BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACTISEAL EVD 1.9MM CATH SET

    MDR report key: 1700922 · Received May 26, 2010

    Report

    Report Number
    1226348-2010-00169
    Event Type
    Injury
    Date Received
    May 26, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC. MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K021653
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L LOT#: 422748. UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THIS COMPLAINT HAS BEEN CONFIRMED. A SEGMENT OF THE DEVICE WAS RETURNED WITH TWO CUTS AT ONE OF THE ENDS. IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE CUTS. ALSO RETURNED WERE TWO OF THE SAME UNUSED PRODUCTS. THESE DEVICES WERE TESTED AND THEY PASSED THE TESTS. THE LOT RECORDS WERE REVIEWED AND THEY CONFIRMED THAT THE DEVICES CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. AT THE PRESENT TIME, THIS IS THE FIRST COMPLAINT REPORTED FOR THIS TYPE OF ISSUE, AND IT IS CONSIDERED TO BE AN ISOLATED INCIDENT. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    CUSTOMER (B) (6) MEDICAL CENTER IS REPORTING THAT: "THEY HAVE HAD 4 - 6 LLBEVD, 82-1749, HAVE HOLES IN THEM IN THE AREA JUST DISTAL TO WHERE THE CATHETER CONNECTS TO THE DRAINAGE SYSTEM. THEY USED THE INTEGRA DRAIN. I DON'T HAVE THE SPECIFIC LOT, BUT DO HAVE A SAMPLE THAT THEY CUT OFF THE CATHETER WHERE THE HOLE WAS. AND I'VE PICKED UP ONE EACH OF THE TWO LOT NUMBERS THEY HAVE". ADDITIONAL INFORMATION RECEIVED FROM THE SALES REP REVEALED THE CUSTOMER COULD SEE CSF LEAKING FROM THE CATHETER. THEY THEN CUT THAT PIECE OFF AND RECONNECTED IT. THE CUSTOMER DID NOT INDICATE AT THIS TIME WHETHER OR NOT THERE HAS BEEN AN ADVERSE EVENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACTISEAL EVD 1.9MM CATH SET SHUNT, CENTRAL NERVOUS SYSTEM AND COMPS JXG CODMAN & SHURTLEFF, INC. MEDOS S.A. NA 422743

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention