BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 9844946 · Received March 17, 2020

    Report

    Report Number
    1036844-2020-00085
    Event Type
    Malfunction
    Date Received
    March 17, 2020
    Date of Event
    February 19, 2020
    Report Date
    February 20, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    BSO
    PMA / PMN Number
    K140110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL NEEDLE WITH NO RELEVANT FINDINGS. THE CUSTOMER REPORTED THE EPIDURAL NEEDLE'S TIP WAS BENT. THE CUSTOMER RETURNED ONE SEALED REPRESENTATIVE KIT FROM THE SAME LOT # AS REPORTED ON THE COMPLAINT (23F19F0291) FOR INVESTIGATION (REFERENCE FILES (B)(4)). THE ACTUAL COMPLAINT SAMPLE WAS NOT RECEIVED. THE RETURNED KIT WAS OPENED, AND THE EPIDURAL NEEDLE WAS REMOVED AND WAS VISUALLY EXAMINED. VISUAL EXAMINATION OF THE RETURNED NEEDLE REVEALED THAT THE NEEDLE APPEARS TYPICAL. THE NEEDLE BEVEL APPEARS POLISHED AND SMOOTH WITH NO OBSERVED BURRS. THE NEEDLE CANNULA APPEARS TYPICAL. NO DEFECTS OR ANOMALIES WERE OBSERVED. A DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED EPIDURAL NEEDLE. THE ID MEASURED 0.046IN (1.17MM) (REF-(B)(4)), WHICH IS WITHIN SPECIFICATION OF 1.17MM PER GRAPHIC KZ-05500-007; REV 9. SINCE THE NEEDLE RETURNED WAS FROM A SEALED REPRESENTATIVE SAMPLE, 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; REV 3 USING THE RETURNED COMPONENTS AND A WEIGHT (REF-(B)(4)). 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 WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. A DESIGN HISTORY REVIEW WAS PERFORMED FOR PART # KZ-05500-007 AS A PART OF THIS COMPLAINT INVESTIGATION. THERE HAVE BEEN NO MATERIAL CHANGES FOR THIS PART 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 VISUALLY INSPECTED WITH NO ISSUE FOUND. THE REPORTED COMPLAINT OF A BENT NEEDLE COULD NOT BE CONFIRMED BASED ON THE SAMPLE RECEIVED. THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED; ONLY A REPRESENTATIVE SAMPLE WAS RECEIVED. SINCE A REPRESENTATIVE SAMPLE WAS RETURNED, FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED CATHETER AND NEEDLE. THE RETURNED 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 WAS FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE NEEDLE WITH NO RELEVANT FINDINGS. 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 IN PLACING A LABOR EPIDURAL, THERE WAS SOME DIFFICULTY DUE TO PATIENT MOVEMENT AND POOR POSITIONING. THERE WAS CONTACT WITH BONE, BUT THE NEEDLE WAS REDIRECTED TO FIND THE EPIDURAL SPACE. NEVERTHELESS, THERE WAS A GOOD LOSS OF RESISTANCE (CLEAR INDICATION THAT THE NEEDLE WAS IN THE EPIDURAL SPACE), AND MEDICATION WAS EASILY DOSED THROUGH THE NEEDLE. HOWEVER, WHEN I TRIED TO PASS THE EPIDURAL CATHETER THROUGH THE NEEDLE, THE CATHETER MOVEMENT WAS BLOCKED AND WOULD NOT PASS THROUGH THE TIP OF THE NEEDLE. AFTER MULTIPLE ATTEMPTS, I ABORTED THE PROCEDURE AND REMOVED THE NEEDLE, WHERE I FOUND THAT THE BEVEL-TIP WAS SIGNIFICANTLY BENT, MAKING IT IMPOSSIBLE FOR THE PLASTIC CATHETER TO PASS THROUGH. I HAD TO START OVER AGAIN WITH A NEW NEEDLE/KIT. EVENTUALLY, THE 2ND KIT ALLOWED PLACEMENT OF THE EPIDURAL CATHETER, BUT THE DELAY OF TREATMENT CAUSED ADDITIONAL PAIN FOR THE PATIENT.

    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 IN PLACING A LABOR EPIDURAL, THERE WAS SOME DIFFICULTY DUE TO PATIENT MOVEMENT AND POOR POSITIONING. THERE WAS CONTACT WITH BONE, BUT THE NEEDLE WAS REDIRECTED TO FIND THE EPIDURAL SPACE. NEVERTHELESS, THERE WAS A GOOD LOSS OF RESISTANCE (CLEAR INDICATION THAT THE NEEDLE WAS IN THE EPIDURAL SPACE), AND MEDICATION WAS EASILY DOSED THROUGH THE NEEDLE. HOWEVER, WHEN I TRIED TO PASS THE EPIDURAL CATHETER THROUGH THE NEEDLE, THE CATHETER MOVEMENT WAS BLOCKED AND WOULD NOT PASS THROUGH THE TIP OF THE NEEDLE. AFTER MULTIPLE ATTEMPTS, I ABORTED THE PROCEDURE AND REMOVED THE NEEDLE, WHERE I FOUND THAT THE BEVEL-TIP WAS SIGNIFICANTLY BENT, MAKING IT IMPOSSIBLE FOR THE PLASTIC CATHETER TO PASS THROUGH. I HAD TO START OVER AGAIN WITH A NEW NEEDLE/KIT. EVENTUALLY, THE 2ND KIT ALLOWED PLACEMENT OF THE EPIDURAL CATHETER, BUT THE DELAY OF TREATMENT CAUSED ADDITIONAL PAIN FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306734 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. 23F19F0291

    Patients

    Seq Age Sex Outcome Treatment
    1