BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELSITE ACCESS PORT

    MDR report key: 4338241 · Received December 9, 2014

    Report

    Report Number
    9612452-2014-00025
    Event Type
    Injury
    Date Received
    December 9, 2014
    Date of Event
    September 10, 2014
    Report Date
    November 27, 2014
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH HISTORY REVIEW: THE MFR FILE WAS REVIEWED. IT IS COMPLIANT WITHOUT SPECS AND NO ABNORMALITY WAS DETECTED. NO OTHER COMPLAINT FROM ANOTHER HEALTH FACILITY WAS REPORTED TO US ON THIS ACCESS PORTS BATCH. INVESTIGATION: NO DEVICE RETURNED FOR EVAL. NO X-RAY PICTURES RETURNED FOR EVAL. CONCLUSION: THE ELEMENTS IN OUR POSSESSION CANNOT ALLOW US TO CONCLUDE ON THE ROOT CAUSE OF THIS INCIDENT. OUT COMPLAINT HANDLING DATABASE DOES NOT SHOW ANY INCREASING TREND FOR THIS TYPE OF COMPLAINT. IT IS AN ISOLATED CASE. NO CORRECTIVE ACTION IS ENVISAGED. IT IS WORTH NOTING THAT THE CELSITE ACCESS PORT, REFERENCE 4430409 IS NOT CLEARED IN THE US, BUT THIS DEVICE HAS THE SAME CATHETER AS THE REFERENCED 05433750 (K130576).

    Description of Event or Problem · 1

    "A CELSITE CATHETER WAS IMPLANTED ON (B)(6) 2014 WITHOUT ANY COMPLICATION. WHEN THE PT WOULD BE SUBMITTED TO THE SIXTH CYCLE OF CHEMOTHERAPY, SHE REFERS PAIN, FURTHER THE CATHETER DOES NOT EVIDENCED RETURN. THE DOCTOR DID ORDERED C-RAY IMAGES TO SEE THE CATHETER. IN FACT IT WAS BROKEN. SO THEN, THE PT WAS SUBJECT TO A SURGERY WITH ANESTHESIA. THE CATHETER WAS REMOVED WITHOUT ANY COMPLICATIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792617 CELSITE ACCESS PORT ACCESS PORT SYSTEM LJT B. BRAUN MEDICAL SAS NA M245384T

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention