BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANTEX CENTRAL VENOUS CATHETHER WITH OLIGON MATERIAL WITH OR

    MDR report key: 1112047 · Received August 4, 2008

    Report

    Report Number
    6000002-2008-08320
    Event Type
    Malfunction
    Date Received
    August 4, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 16, 2008
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    FOZ
    PMA / PMN Number
    K992532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED. CUSTOMER REPORT WAS CONFIRMED. THE CATHETER WAS FOUND TO HAVE THREE CRACKS / KINKS / TEARS IN THE BODY TUBE. THE DAMAGE IS LOCATED 35MM, 60MM, 70MM DISTAL OF THE BACKFORM. THERE ALSO APPEARS TO BE A SMALL SECTION OF THE TUBE MISSING AT THE 70MM DAMAGED AREA. THREE OF THE EXTENSION TUBES APPEAR TO HAVE BEEN CUT IN HALF NEAR THE BACKFORM, AND THE PROXIMAL SECTIONS WITH THE HUBS WERE NOT RETURNED. THE DISTAL EXTENSION TUBE IS THE ONLY REMAINING AND INTACT EXTENSION TUBE. FOLLOW UP WITH THE CUSTOMER INDICATED THAT THE INSERTION SITE WAS CLEANED WITH CHLORHEXIDINE GLUCONATE 5% IN ALCOHOL AND THE DRUGS ADMINISTERED WAS FLOXAPEN. AS PER THE DIRECTIONS FOR USE INDICATE - DO NOT USE ACETONE OR ISOPROPYL ALCOHOL ON THE CATHETER. THIS INFORMATION HAS BEEN COMMUNICATED TO THE CUSTOMER.

    Description of Event or Problem · 1

    REPORTEDLY, DURING USE LEAKAGE OCCURRED AT THE HEIGHT OF THE SKIN INSERTION. AFTER REMOVAL OF THE VANTEX, THE CATHETER SEEMED TO BE DAMAGED. IT WAS FURTHER STATED THAT PROBABLY ANTIBIOTICS DID NOT ENTER THE VEIN AND WAS GIVEN SUBCUTANEOUS, BUT THE CLINICIAN IS NOT 100% SURE. ONE OTHER VANTEX CATHETERS ALSO LEAKED AT THE HEIGHT OF THE INSERTION SITE. CLINICIAN SUGGESTED THAT CATHETER DOESN'T LIKE FLOXAPEN (FLUCLOXACILLIN). THREE DEVICES WERE REPORTED; HOWEVER, ONLY ONE WAS RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANTEX CENTRAL VENOUS CATHETHER WITH OLIGON MATERIAL WITH OR CENTRAL VENOUS CATHETER SET FOZ EDWARDS LIFESCIENCES, PR A4816HSI 58481140

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other