BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM LOW PROFILE PORT W/ATT GROSHONG 8.0 FR CATH

    MDR report key: 77997 · Received March 17, 1997

    Report

    Report Number
    1720496-1997-00172
    Event Type
    Malfunction
    Date Received
    March 17, 1997
    Date of Event
    February 10, 1997
    Report Date
    February 17, 1997
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLICATED PRODUCT IS A PORT WITH ATTACHABLE CATHETER. THE PRODUCT RECEIVED FOR EVALUATION IS A 14.8 INCH LONG ASSEMBLY OF PORT WITH AN ATTACHED SINGLE LUMEN CATHETER. FIVE SEPARATE DEPTH MARKERS ARE PRINTED ALONG THE LENGTH OF THE CATHETER. THE MOST PROXIMAL IS THE FIVE-DOT MARKER 4.7 INCHES FROM THE ASSEMBLY'S PROXIMAL END. A LOT HISTORY REVIEW REVEALS NO RELATED NFG ISSUES AND NO OTHER COMPLAINTS FOR THIS LOT. GROSS EXAM REVEALS AN INDETERMINATE NUMBER OF NEEDLE PUNCTURE SITES IN THE PORT SEPTUM, SMALL FLAKES OF BLOOD RESIDUE TRAPPED BETWEEN THE CATH-LOCK AND THE CATHETER AND A DRIED, WHITE (MEDICINAL OR DECONTAMINATION) RESIDUE INTERMITTENTLY THROUGHOUT THE LENGTH OF THE CATHETER. UNDER 10X MAGNIFICATION, THE MAJORITY OF NEEDLE PUNCTURES APPEAR TO BE MADE BY NON-CORING NEEDLES, HOWEVER, SOME GOUGING IS PRESENT THAT MAY BE THE RESULT OF HYPODERMIC (CORING) NEEDLES OR EXPLANTATION. TACTUAL EXAM REVEALS AN APPROXIMATE .2 INCH AREA OF TENSILE WEAKNESS BEGINNING 1.6 INCHES FROM THE PROXIMAL END OF THE PORT/CATHETER ASSEMBLY. UNDER 30X MAGNIFICATION, TWO PERPENDICULAR CUTS ARE FOUND IN THE CATHETER TUBING IN THE AREA OF THE TENSILE WEAKNESS. THE MOST SIGNIFICANT CUT IS APPROXIMATELY .1 INCH LONG AND PENETRATES TO THE INNER DIAMETER THROUGHOUT THE LENGTH OF THE CUT. BOTH CUTS HAVE STEEP ANGLES WITH SHARP, WELL DEFINED EDGES AND SMOOTH, REFLECTIVE WALLS INDICATING A CUTTING INSTRUMENT SUCH AS A SCALPEL. WHILE THE SECOND CUT IS SIMILAR IN LENGTH TO THE FIRST, THE PENETRATION FROM OUTER DIAMETER TO INNER DIAMETER IS LIMITED TO ONE END OF THE CUT AND SOME SLICING DAMAGE TO THE INNER DIAMETER. THIS SUGGESTS THE CUTTING INSTRUMENT MAY HAVE BEEN A POINTED (#11) BLADE PENETRATING FROM THE OUTER DIAMETER. FLUSHING THE ASSEMBLY WITH A WATER-FILLED 12CC SYRINGE AND 19GA. NON-CORING NEEDLE DEMONSTRATES CATHETER AND PORT PATENCY. SMALL LEAKS ARE NOTED EXITING THE HOLES IN THE CATHETER. ASPIRATION RESULTS IN DRAWING AIR INTO THE SYRINGE. THE COMPLAINT OF SUBCUTANEOUS CATHETER LEAKAGE IS CONFIRMED. ALTHOUGH THE CATHETER HAD BEEN IN PLACE APPROXIMATELY 5 MONTHS PRIOR TO THE COMPLAINT OCCURRING, THERE IS NO INDICATION IN THE COMPLAINT FILE OF HOW OFTEN THE PORT HAD BEEN ACCESSED (IF AT ALL) OR COMPLICATIONS ARISING DURING THAT TIME. THE TYPE OF DAMAGE IN EVIDENCE SUGGESTS THE LEAK OCCURRED AS A RESULT OF SHARP INSTRUMENTATION. ADDITIONALLY, THE PRODUCT INSTRUCTIONS FOR USE RECOMMENDS STRICT USE OF NON-CORING NEEDLES FOR PORT ACCESS.

    Description of Event or Problem · 1

    THE PORT WAS PLACED 9/11/97 FOR CHEMOTHERAPY. IT WAS REPORTED THAT THE PORT WAS UNABLE TO BE ASPIRATED. THE PT FELT PAIN AT THE NECK AND THE NURSE SAW A "GROWTH" AT THAT POINT. CONTRAST MATERIAL WAS INJECTED AND LEAKED FROM THE CATHETER. THE PORT WAS REMOVED 2/10/97. NO PT INJURY WAS REPORTED TO HAVE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUM LOW PROFILE PORT W/ATT GROSHONG 8.0 FR CATH Implant INTRAVASCULAR IMPLANTED PORTS LJT BARD ACCESS SYSTEMS 0606150 36CG3774

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention