BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC

    MDR report key: 21392 · Received February 9, 1995

    Report

    Report Number
    21392
    Event Type
    Injury
    Date Received
    February 9, 1995
    Date of Event
    July 13, 1994
    Report Date
    January 31, 1995
    Manufacturer
    PHARMACIA DELTEC, INC.
    Product Code
    LKG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS LEARNED THAT A 49 YEAR OLD FEMALE HAD THIS PORT-A-CATH SYSTEM IMPLANTED ON JULY 10, 1994. THE INTERVENTIONAL RADIOLOGY, HAD ELECTED TO IMPLANT THE FULL SIZE PORT-A-CATH SYSTEM INTO THE LEFT ANTECUBITAL AREA OF AN OBESE FEMALE PATIENT. ON THE THIRD DAY FOLLOWING THE IMPLANTATION, THE PATIENT COMPLAINED OF PAIN DURING ACCESS OF THE SYSTEM. A SUBSEQUENT VENOGRAM SHOWED THAT THE CATHETER HAD DISCONNECTED FORM THE PORTAL. THERE WAS NO INDICATION OF EMBOLIZATION OF THE CATHETER. THE COMPLETE PORT-A-CATH SYSTEM WAS SUBSEQUENTLY EXLANTED. YOU INDICATED THAT THERE WAS NO REPORT OF INJURY AS A RESULT OF THE INCIDENT NOR WAS THERE ANY INCIDENT RELATED MEDICAL SEQUELAE. THE EXPLANTED PORT-A-CATH SYSTEM WAS RETURNED TO MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTEC Implant PORT-A-CATH LKG PHARMACIA DELTEC, INC. UNKNOWN 20048

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention LEFT NEPHROSTOMY REPLACEMENT - 7/15/94| REPLACEMENT OF CATHETER WITH VITAL PORT CATHETER -| 7/13/94