BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTED PORT WITH GROSHONG CATH

    MDR report key: 4924330 · Received July 13, 2015

    Report

    Report Number
    MW5044382
    Event Type
    Injury
    Date Received
    July 13, 2015
    Date of Event
    July 11, 2015
    Report Date
    July 13, 2015
    Manufacturer
    BARD
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD POWER PORT INSERTED IN RIJ HERE (B)(6) 2006. PORT NOW NON-FUNCTIONING AND PT WAS EXPERIENCING PAIN IN HER NECK WHEN ACCESSED. TAKEN TO SURGERY ON (B)(6) 2015 UNDER MAC FOR REMOVAL OF OLD PORT AND INSERTION OF A NEW POWER POT IN LIJ. NO COMPLICATIONS NOTED IN IMMEDIATE POSTOP NOTE, EBL 10 ML. CXR TAKEN IN PACU FOR PLACEMENT REVEALED: LIJ PORT IN PLACE, AND DISTAL 1/2 OF RIJ PORT PRESENT WITH DISTAL TIP PROJECTED OVER MID-THORACIC SPINE. PT RETURNED TO SURGERY FROM PACU AGAIN UNDER MAC TO RETRIEVE RETAINED CATHETER TIP FROM RIJ; EBL 10 ML. REPORT IS IN POSSESSION OF PORT THAT WAS REMOVED. PORT INITIALLY REMOVED WAS ATTACHED TO APPROX 5.5 OF TUBING. PORTION OF TUBING REMOVED DURING 2ND SURGERY IS APPROX 6.5" LONG AND THIS PART OF THE TUBING HAS HASHMARK MEASUREMENT MARKS INDICATING 1/2" SEGMENTS WITH THE NUMBERS 5, 10, AND 15 ON THIS SEGMENT OF TUBING AND WITH THE BLACK MARKING VISIBLE AT THE DISTAL END OF THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454414 IMPLANTED PORT WITH GROSHONG CATH IMPLANTED PORT WITH GROSHONG CATH LJS BARD 0602830 REQG0183

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention