BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG 5 FR D/L PICC PERIPHERALLY INSERTED CENTRAL VE

    MDR report key: 1436857 · Received May 21, 2009

    Report

    Report Number
    3006260740-2009-00184
    Event Type
    Malfunction
    Date Received
    May 21, 2009
    Date of Event
    March 12, 2009
    Report Date
    March 15, 2009
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    FOZ
    PMA / PMN Number
    K904558
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF LEAKS IN THE PICC TUBING WAS CONFIRMED AND APPEARED USER RELATED. AN ATTEMPT WAS MADE TO FLUSH THE LUMENS OF THE CATHETER WITH WATER FROM A 12CC SYRINGE. THE WHITE LUMEN WAS PATENT TO INFUSION. THE RED LUMEN WAS OCCLUDED. A SPRAYING LEAK EMANATED FROM A SPLIT JUST DISTAL TO THE BIFURCATION WHEN THE RED LUMEN WAS ACCESSED. TACTILE EVALUATION OF THE CATHETER REVEALED MULTIPLE AREAS OF POSSIBLE OCCLUSIONS, AS WELL AS AN AREA WITH NECKING, AND ANOTHER AREA WHICH CONTAINED IMPRESSIONS. THERE ARE TWO LONGITUDINAL U-SHAPED SPLITS VISIBLE ON THE CATHETER. ONE OF THE SPLITS IS FOUND JUST DISTAL TO THE BIFURCATION. IT IS APPROXIMATELY 0.1 INCHES LONG. THE OTHER SPLIT IS FOUND BETWEEN THE 12 AND 13 CM DEPTH MARKINGS AND IS LESS THAN 0.1 INCHES LONG. MICROSCOPIC EVALUATION (15-65X) OF THE SPLITS REVEALED THAT THE EDGES OF THE SPLITS APPEAR DULL AND GRANULAR. BOTH SPLITS WERE ENTIRELY THROUGH THE CATHETER WALL. A VEIN PICK WAS USED TO OPEN UP THE SPLITS. A WHITE CRYSTALLINE RESIDUE WAS FOUND WITHIN THE LUMEN OF THE CATHETER AROUND THE DISTAL SPLIT. A VEIN PICK WAS ALSO USED TO OPEN THE 3-POSITION VALVES. THE WHITE LUMEN'S VALVE HAD BLOOD RESIDUE WITHIN THE LUMEN. THE RED LUMEN'S VALVE CONTAINED AN ORANGE/RED CRYSTALLINE RESIDUE WHICH POSSIBLY OCCLUDED THE LUMEN. THE DAMAGE FOUND ON THE CATHETER TUBING CONTAINS TRAITS THAT ARE CONSISTENT WITH A BURST SECONDARY TO OVER PRESSURIZATION OF THE CATHETER. A PROPER FLUSHING PROTOCOL MUST BE MAINTAINED IN ORDER TO REDUCE THE RISK OF OCCLUSION. THE IFU CONTAINS SUGGESTED CATHETER MAINTENANCE, "FOR INTERMITTENT USE, FLUSH THE CATHETER WITH SALINE ONCE EACH WEEK OR AFTER EACH USE." THE IFU ALSO CONTAINS INSTRUCTIONS FOR AN OCCLUDED CATHETER, "CATHETERS THAT PRESENT RESISTANCE TO FLUSHING AND ASPIRATION MAY BE PARTIALLY OR COMPLETELY OCCLUDED. DO NOT FLUSH AGAINST RESISTANCE. IF THE LUMEN WILL NEITHER FLUSH NOR ASPIRATE AND IT HAS BEEN DETERMINED THAT THE CATHETER IS OCCLUDED WITH BLOOD, A DECLOTTING PROCEDURE PER INSTITUTION PROTOCOL MAY BE APPROPRIATE." A CHR IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER INFORMATION HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    NEEDLE LEAKING NEAR THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG 5 FR D/L PICC PERIPHERALLY INSERTED CENTRAL VE FOZ C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention