BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 9785938 · Received March 4, 2020

    Report

    Report Number
    1036844-2020-00092
    Event Type
    Malfunction
    Date Received
    March 4, 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

    QN#(B)(4). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL NEEDLE WITH NO RELEVANT FINDINGS. 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 ROOT CAUSE FOR THIS COMPLAINT INVESTIGATION COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE ACTUAL SAMPLE. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS PROVIDED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON THE EPIDURAL 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 THE SAMPLE.

    Description of Event or Problem · 0

    THE REPORT STATES: 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 TUOHY 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 HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE REPORT STATES: 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 TUOHY 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
    250536 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION CATHETER BSO ARROW INTERNATIONAL INC. 23F19F0291

    Patients

    Seq Age Sex Outcome Treatment
    1