BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 7304603 · Received February 28, 2018

    Report

    Report Number
    1036844-2018-00068
    Event Type
    Malfunction
    Date Received
    February 28, 2018
    Date of Event
    February 5, 2018
    Report Date
    February 5, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    PMA / PMN Number
    K103658
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL NEEDLE AND EPIDURAL CATHETER WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED DIFFICULTY THREADING THE CATHETER THROUGH THE NEEDLE. THE CUSTOMER RETURNED ONE SEALED KIT FROM THE SAME LOT # AS REPORTED ON THE COMPLAINT (23F17L0221). A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED EPIDURAL NEEDLE. INNER DIAMETER (ID) MEASUREMENT OF THE RETURNED NEEDLE REVEALED A VALUE OF 0.046" (1.17MM) USING PIN GAUGES (C05157), WHICH IS WITHIN SPECIFICATION OF 1.17MM PER GRAPHIC KZ-05500-007; REV 9. A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED CATHETER. OUTER DIAMETER (OD) MEASUREMENT OF THE RETURNED CATHETER REVEALED A VALUE OF 1.07MM USING A CALIPER (C05155), WHICH IS WITHIN SPECIFICATION (1.115MM MAXIMUM) PER GRAPHIC KZ-05400-002, REV 9. A FUNCTIONAL TEST WAS PERFORMED BY ATTEMPTING TO THREAD THE RETURNED CATHETER THROUGH THE RETURNED EPIDURAL NEEDLE. THE CATHETER WAS THREAD AT THE DISTAL END AND WOULD THREAD THROUGH THE EPIDURAL NEEDLE WITH NO RESISTANCE MET. A DRAG TEST WAS PERFORMED PER PIP-013 USING THE RETURNED COMPONENTS OTHER REMARKS: AND A WEIGHT (C05406). THE CATHETER COULD THREAD THROUGH THE RETURNED NEEDLE WITH NO RESISTANCE MET. THE COMPONENTS PASSED THE DRAG TEST. SPECIFICATIONS PER GRAPHIC KZ-05500-007 REV. 9 AND KZ-005400-002; REV 9 WERE REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. A DESIGN HISTORY REVIEW WAS PERFORMED FOR PART # NZ-05500-001 AND KZ-005400-002 AS A PART OF THIS COMPLAINT INVESTIGATION. THERE HAVE BEEN NO MATERIAL CHANGES FOR THESE PARTS DURING THE LAST TWO YEARS THAT COULD HAVE LED TO THIS COMPLAINT. A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS THE COMPLAINT COULD NOT BE CONFIRMED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE ACTUAL COMPLAINT SAMPLE. THE REPRESENTATIVE SAMPLE RECEIVED WAS FUNCTIONALLY TESTED AND DIMENSIONALLY INSPECTED WITH NO ISSUE FOUND. THE REPORTED COMPLAINT OF DIFFICULTY THREADING THE EPIDURAL CATHETER THROUGH THE NEEDLE COULD NOT BE CONFIRMED BASED ON THE SAMPLE RECEIVED. THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED; ONLY A REPRESENTATIVE SAMPLE WAS RECEIVED. THE RETURNED EPIDURAL CATHETER COULD BE THREAD THROUGH THE RETURNED NEEDLE WITH NO RESISTANCE MET. THE RETURNED COMPONENTS PASSED A FUNCTIONAL DRAG TEST, AND THE RETURNED NEEDLE ID AND RETURNED CATHETER OD WERE FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL NEEDLE AND CATHETER WITH NO EVIDENCE TO SUGGEST A MANUFACTURING RELATED CAUSE. A POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED OR WITHOUT THE ACTUAL COMPLAINT SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE CLINICIAN WAS ATTEMPTING TO THREAD THE EPIDURAL CATHETER THROUGH THE TUOCHY NEEDLE HE BEGAN TO FEEL RESISTANCE AND WAS NOT ABLE TO ADVANCE THE CATHETER. UPON WITHDRAWING THE CATHETER FROM THE NEEDLE HE NOTICED THAT THE CATHETER WAS SHEARED TOWARDS THE DISTAL TIP. HE GRABBED ANOTHER KIT FROM THE SAME LOT NUMBER AND SUCCESSFULLY PERFORMED THE PROCEDURE WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CLINICIAN WAS ATTEMPTING TO THREAD THE EPIDURAL CATHETER THROUGH THE TUOCHY NEEDLE HE BEGAN TO FEEL RESISTANCE AND WAS NOT ABLE TO ADVANCE THE CATHETER. UPON WITHDRAWING THE CATHETER FROM THE NEEDLE HE NOTICED THAT THE CATHETER WAS SHEARED TOWARDS THE DISTAL TIP. HE GRABBED ANOTHER KIT FROM THE SAME LOT NUMBER AND SUCCESSFULLY PERFORMED THE PROCEDURE WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146395 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION KIT CAZ ARROW INTERNATIONAL INC. 23F17LO221

    Patients

    Seq Age Sex Outcome Treatment
    1