BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE ACCESS PORT

    MDR report key: 3576888 · Received January 6, 2014

    Report

    Report Number
    9612452-2014-00001
    Event Type
    Injury
    Date Received
    January 6, 2014
    Date of Event
    November 13, 2013
    Report Date
    January 3, 2014
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW: WE HAVE CHECKED THE MANUFACTURING 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 PART OF THE CATHETER WAS RETURNED FOR EVALUATION. THEY ARE COMPLIANT WITH OUR SPECIFICATIONS. THE RUPTURE FACIES IS IRREGULAR. THE CATHETER WAS PROBABLY PINCHED OR KINKED AT THE LEVEL OF THE RUPTURE. THE X-RAY PICTURES WERE NOT FORWARDED FOR ANALYSIS. CONCLUSION: THE RETURNED DEVICE IS COMPLIANT WITH OUR SPECIFICATIONS. AS NEITHER THE DISTAL PART OF THE CATHETER NOR COPIES OF X-RAY PICTURES WERE RETURNED TO US FOR EVALUATION, WE CANNOT CONCLUDE AS TO THE REAL CAUSE OF THIS INCIDENT. CATHETER RUPTURE IS A KNOWN COMPLICATION OF THE ACCESS PORT IMPLANTATION. (B)(4). 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

    (B)(6) 2013: CELSITE T305 IMPLANTED IN PATIENT VIA RIGHT SUB-CLAVIAN VEIN. VEIN OF CHOICE, CEPHALIC VEIN, WAS NOT SUITABLE. (B)(6) 2013: PATIENT ENTERED THE HOSPITAL FOR AMBULATORY CHEMOTHERAPY TREATMENT. DURING RINSING OF THE ACCESS PORT SYSTEM PRIOR TO TREATMENT, SUBCUTANEOUS SWELLING WAS NOTED. CHEMOTHERAPY TREATMENT WAS SUBSEQUENTLY GIVEN VIA A PERIPHERAL VEIN. (B)(6) 2013: ANGIOGRAPHY WAS PERFORMED WHICH SHOWED THAT A PART OF THE CATHETER IS THE RIGHT SIDE OF THE HEART. (B)(6) 2013: IN ORDER TO LOCALIZE PRECISELY THE FOREIGN BODY, A CT SCAN WAS PERFORMED. THE CATHETER FRAGMENT IS SEEN IN THE RIGHT VENTRICLE. THE ACCESS PORT WAS REMOVED AND SENT TO THE MANUFACTURER. THE DISTAL PART OF THE CATHETER WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8145 CELSITE ACCESS PORT ACCESS PORT SYSTEM LJT B. BRAUN MEDICAL SAS NA M1792850

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention