BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE ACCESS PORT

    MDR report key: 3682759 · Received March 5, 2014

    Report

    Report Number
    9612452-2014-00005
    Event Type
    Injury
    Date Received
    March 5, 2014
    Date of Event
    November 25, 2013
    Report Date
    February 28, 2014
    Manufacturer
    BBRAUN MEDICAL SAS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW: WE HAVE CHECKED THE MFG FILE OF THIS LOT OF CELSITE ACCESS PORTS, WHICH COMPLIES WITH OUR SPECIFICATIONS AND DOES NOT PRESENT ANY ABNORMALITY. NO OTHER SIMILAR INCIDENTS WERE DECLARED TO US CONCERNING THIS LOT OF ACCESS PORTS, SOLD SINCE (B)(4) 2013. INVESTIGATION RESULTS: THE ACCESS PORT HOUSING AS WELL AS THE PROXIMAL SEGMENT OF THE CATHETER (9.6 CM) WAS RETURNED FOR EVAL. THEY ARE COMPLIANT WITH OUR SPECIFICATIONS. ABOUT ONE THIRD OF THE FRACTURE SURFACE IS SHINY AND CUT CLEAR AND THE OTHER PART IS IRREGULAR. THIS SEEMS TO PROVE THAT THE CATHETER WAS PREVIOUSLY DAMAGED BY A SHARP OBJECT AND THE PT MOVEMENTS CAUSED THE EXTENSION OF THE DEFECT, LEADING FIRSTLY TO A LEAK THEN TO A PREMATURE RUPTURE. THE X-RAY PICTURE SUPPLIED SHOWS THAT THE CATHETER RUPTURE OCCURRED AT THE BASE OF THE PT'S NECK. CONCLUSION: THE PORT HAS BEEN IMPLANTED FOR SLIGHTLY MORE THAN 2 MONTHS ONLY. THE FRACTURE SURFACE ALLOWS US TO THINK THAT THIS PREMATURE RUPTURE IS DUE TO CATHETER DAMAGE PROBABLY DONE DURING THE IMPLANTATION PROCEDURE. IT IS AN ISOLATE CASE. NO CORRECTIVE ACTION IS ENVISAGED. IT IS WORTH NOTING THAT THE CELSITE T305 ACCESS PORT, REFERENCE (B)(4) IS NOT CLEARED IN THE US, BUT THIS DEVICE IS SIMILAR TO THE REFERENCE (B)(4) (K130576).

    Description of Event or Problem · 1

    ON (B)(6) 2013: CELSITE T305 IMPLANTED IN PT VIA RIGHT JUGULAR VEIN. ON (B)(6) 2013: FOURTH CHEMOTHERAPY TREATMENT. NO BLOOD ASPIRATION POSSIBLE. BURN FELT DURING INJECTION. CHEMOTHERAPY STOPPED AND ADMINISTRATED BY PERIPHERAL ACCESS. A RUPTURE AND MIGRATION OF THE CATHETER IS DETECTED. IT IS WORTH NOTING THAT DURING THE 3RD CHEMOTHERAPY TREATMENT, THE PT ALSO FELT A BURNING SENSATION DURING THE PORT RINSING, WHICH DECREASED AFTER A WHILE. ON (B)(6) 2013: REMOVAL BY INTERVENTIONAL RADIOLOGY OF THE DISTAL PART OF THE CATHETER LOCATED IN THE SVC AND RIGHT ATRIUM. ON (B)(6) 2013: REMOVAL OF ACCESS PORT AND THE PROXIMAL PART OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132992 CELSITE ACCESS PORT ACCESS PORT SYSTEM LJT BBRAUN MEDICAL SAS NA M1560850

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention