BEUDAMED
    FDA Adverse Event Other Summary report: N

    STANDARD T-PORT

    MDR report key: 2222554 · Received August 12, 2011

    Report

    Report Number
    2032582-2011-00004
    Event Type
    Other
    Date Received
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    LJT
    PMA / PMN Number
    K073210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2011 PFM CLOSED OUT THIS COMPLAINT AS THERE WAS NO SAMPLE PROVIDED TO COMPLETE A THOROUGH INVESTIGATION. A DHR REVIEW WAS CONDUCTED: RECORDS FOR LOT 1026CS WERE COMPLETE. THERE WERE NO SIMILAR COMPLAINTS OF THIS NATURE REPORTED TO PFM. THE INVESTIGATION FOUND THE REPORTED FAILURE MODE TO BE A PROBLEM WITH NEEDLE PLACEMENT BY THE USER. THIS TYPE OF FAILURE MODE IS COVERED IN THE RISK ANALYSIS OF THE DEVICE. ON (B)(4) 2011 PFM RE-OPENED THIS COMPLAINT AS PFM RECEIVED THE NON-CONFORMING SAMPLE AND FORWARDED IT FOR EVAL. ON (B)(4) 2011 PFM RECEIVED THE RESULTS OF THE INVESTIGATION. A FLUSH TEST WAS CONDUCTED AND THE PORT WAS NOT OCCLUDED. ADDITIONALLY THERE WERE NO SIGNS OF LEAKAGE. VISUAL INSPECTION CONFIRMED THAT THE CATHETER WAS CORRECTLY/SAFELY CONNECTED. THE SEPTUM OF THE PORT WAS INSPECTED. SEVERAL PUNCTURE MARKS COULD EASILY BE OBSERVED ON THE SEPTUM (MORE THAN 10) WHICH SUGGESTS THAT THE PORT HAS BEEN USED WITHOUT MANY PROBLEMS PRIOR TO THIS REPORTED INCIDENT. ON THE PORT SEPTUM THERE WERE TWO (2) SIGNIFICANT PUNCTURE MARKS. ONE OF THESE PUNCTURES SEEMS TO HAVE REMOVED A PIECE OF SILICONE FROM THE SEPTUM. THIS SUGGESTS THAT THE PORT HAD BEEN ACCESSED WITH A CORING NEEDLE. THE USE OF A CORING NEEDLE IS KNOWN TO DAMAGE THE SEPTUM OF THE PORT. A REVIEW OF THE RISK ANALYSIS OF THE DEVICE INDICATES THAT THIS FAILURE MODE IS IDENTIFIED AND COVERED. A REVIEW OF THE LABELING SHOWS SEVERAL WARNINGS/PRECAUTIONS TO ACCESS THE PORT SYSTEM WITH ONLY A NON-CORING NEEDLE. NO CORRECTIVE ACTION IS PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    PT'S CAREGIVER REPORTED "DOES NOT WITHDRAW BLOOD, UNABLE TO FLUSH. FLUID BUILD-UP UNDER ARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD T-PORT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS LJT PFM MEDICAL, INC 1026CS

    Patients

    Seq Age Sex Outcome Treatment
    1