BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 6573063 · Received May 17, 2017

    Report

    Report Number
    1036844-2017-00201
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    May 2, 2017
    Report Date
    May 2, 2017
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    QN#(B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL CATHETER AND NEEDLE WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED RECENTLY THREE "WET TAPS" HAVE OCCURRED DURING INSERTION OF THE EPIDURAL CATHETER DUE TO THE CATHETER FEELING STIFFER. THE PUNCTURE OF THE DURA OR A WET TAP IS TYPICALLY A FUNCTION OF THE USER AND IS NOT NECESSARILY A DEFECTIVE COMPONENT. HOWEVER, IF A COMPONENT WOULD BE INVOLVED IN THE CAUSE IT WOULD BE THE EPIDURAL NEEDLE WHICH WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE IFU FOR THIS PRODUCT, (B)(4), WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU FOR THIS PRODUCT WARNS THE USER, "REMOVE NEEDLE AND ATTEMPT NEW PUNCTURE WHEN BLOOD OR SPINAL FLUID IS RETURNED IN PLUNGER BARREL. THE NEEDLE HAS BEEN PLACED INCORRECTLY". A REVIEW OF DESIGN CHANGE HISTORY FOR PART NUMBERS KZ-05400-002 AND EBZ-05400-003 WAS PERFORMED AS A PART OF THIS INVESTIGATION. NO DESIGN CHANGES HAVE BEEN MADE TO THIS PRODUCT IN THE PAST TWO YEARS THAT WOULD HAVE LED TO THIS COMPLAINT. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS A POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. OTHER REMARKS: COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. TYPICALLY, A DURA PUNCTURE OR WET TAP IS A FUNCTION OF THE USER AND IS NOT A FUNCTION OF A DEFECTIVE EPIDURAL NEEDLE COMPONENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE CATHETER AND NEEDLE WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. THEREFORE, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE.

    Description of Event or Problem · 1

    THE REPORT STATES THAT THEY HAD 3 WET TAPS DUE TO THE CATHETER AND THE CATHETER FEELS STIFFER. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    THE REPORT STATES THAT THEY HAD 3 WET TAPS DUE TO THE CATHETER AND THE CATHETER FEELS STIFFER. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353262 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC. 23F16L0698

    Patients

    Seq Age Sex Outcome Treatment
    1