MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT

Catalog Number JC-05400-DCS

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the catheter could not be inserted into the needle which led the doctor to remove the needle and start his procedure again.The patient experienced pain.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter and needle with no relevant findings.The customer reported the catheter could not be inserted into the needle.The customer returned one opened kit with one epidural needle and epidural catheter.The returned components were received with the catheter threaded through the needle's cannula with the distal tip of the catheter at the needle's tip.The returned components were visually examined with and without magnification.Visual examination of the returned epidural needle revealed the needle appears used.Biological material can be seen in the needle's hub, cannula, and tip.Visual examination of the returned catheter revealed the catheter also appears used.Biological material can be seen between the inner coils.No other defects or anomalies were observed.A dimensional inspection was performed on the returned epidural needle.Inner diameter (id) measurement of the returned needle revealed a value of 0.045"/1.143mm using pin gauges (ref-003131), which is within specification (1.15mm + 0.02mm) per graphic kz-80810-001, rev 2.A dimensional inspection was performed on the returned epidural catheter.The outer diameter (od) of the returned catheter measured 1.09mm (caliper: ref-003210), which is within the specification of a maximum of 1.115mm per graphic kz-05400-021; rev 4.A functional test was performed by attempting to thread the returned epidural catheter through the returned epidural needle.The epidural catheter was thread at the distal end and would not thread through the epidural needle due to biological material being present in the needle's hub, cannula, and tip.The needle was flushed to remove the biological material.Threading the catheter through the needle was once again attempted.The catheter threaded completely through the needle's cannula, however, there was a heavy presence of biological material on the distal tip that was still present inside the cannula.The returned needle was once again flushed , and the biological material was removed from the outside of the distal end of the returned catheter.Threading the catheter through the needle was once again attempted.The catheter was thread at the distal end and would thread through the epidural needle with no resistance met.Specifications per graphic kz-80810-001, rev 2 and kz-05400-021; rev 4 were reviewed as a part of this complaint investigation.A design history review was performed for part # kz-80810-001 and kz-05400-021 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 condition of the sample received indicates unintentional user error caused or contributed to this event.The reported complaint of the catheter could not be inserted into the needle was confirmed based on the sample received.The sample was received with the catheter with the catheter threaded through the needle's cannula were the distal tip of the catheter was at the needle's tip.Visual examination of the returned needle revealed biological material could be seen in the needle's hub, cannula, and tip.Functional testing revealed the catheter would not thread through the needle's hub due to the presence of the biological material.The returned needle was flushed to remove the biological material and functional testing was performed again with the catheter threading through the needle's cannula with no issues.The returned needle id and returned catheter od were also found to be within specification.A device history record review was performed on the epidural catheter and needle with no evidence to suggest a manufacturing related cause.Therefore, based upon the condition of the sample received, unintentional user error caused or contributed to this event.

Event Description

It was reported that the catheter could not be inserted into the needle which led the doctor to remove the needle and start his procedure again.The patient experienced pain.The patient's condition was reported as fine.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11032493
• MDR Text Key: 222311429
• Report Number: 3006425876-2020-01102
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2022
• Device Catalogue Number: JC-05400-DCS
• Device Lot Number: 71F20H1068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Date Manufacturer Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1