BEUDAMED
    FDA Adverse Event Other Summary report: N

    L-CATH CATHETER SYSTEMS

    MDR report key: 5313654 · Received September 23, 2004

    Report

    Report Number
    1710034-2004-00085
    Event Type
    Other
    Date Received
    September 23, 2004
    Date of Event
    August 9, 2004
    Report Date
    August 17, 2004
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN MORE DETAILED INFO FROM THE REPORTER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN MORE INFO BECOMES AVAILABLE. RESULTS: VISUAL AND MICROSCOPIC EXAMINATION CONFIRMED THAT THE CATHETER AND YELLOW STRAIN RELIEF ARE SEPARATED FROM THE HUB/BUSHING ASSEMBLY. THE STRAIN RELIEF WAS REMOVED AND CONFIRMED THE CATHETER TUBING WAS BUNCHED WITHIN THE STRAIN RELIEF. NO EVIDENCE OF DAMAGE TO THE METAL BUSHING. MICROSCOPIC EXAMINATION OF THE CATHETER SHOWS NO EVIDENCE OF DAMAGE TO THE CATHETER TUBING THAT WOULD HAVE CAUSED IT TO DISLODGE FROM THE METAL BUSHING. THE STYLET WIRE WAS KINKED IN THREE PLACES ALONG THE LENGTH. CONCLUSION: THE QUALITY ENGINEER WAS UNABLE TO CONCLUSIVELY IDENTIFY THE CAUSE OF THE INCIDENT. THE DAMAGE WITHIN THE STRAIN RELIEF MAY HAVE BEEN CAUSED BY FORCE TO THE CATHETER DURING THE STYLET REMOVAL AD EVIDENCED IN OTHER INCIDENTS OF THIS TYPE. STRESS TO THE CATHETER MAY HAVE CONTRIBUTED TO THE DISLODGING OF THE CATHETER TUBING FROM THE METAL BUSHING/HUB ASSEMBLY. THE USER IS ADVISED THAT EXCESSIVE FORCE WOULD NOT BE USED WHEN REMOVING THE STYLET FROM THE CATHETER FOLLOWING INSERTION. A CORRECTIVE ACTION FOR DIFFICULT STYLET REMOVAL WAS RECENTLY COMPLETED. AS THE LOT NUMBER REPORTED WAS BUILT AFTER THE COMPLETION OF THE CORRECTIVE ACTION, THE ENGINEER IS REEVALUATING DIFFICULT TO REMOVE STYLETS. (B)(4). DATE SUBMITTED: 09/23/2004.

    Description of Event or Problem · 1

    THE INTRODUCER WAS DIFFICULT TO WITHDRAW FOLLOWING INSERTION, RESULTING IN IT DISCONNECTING FROM THE HUB OF CATHETER NEAR THE STRAIN RELIEF. THE CATHETER WAS IMMEDIATELY REMOVED FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH CATHETER SYSTEMS PERCUTANEOUS CATHETERS DQY BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. NA 4021352

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other