MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT NRFIT

Catalog Number TU-05500-NRON

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the user felt resistance when inserting the catheter into the epidural needle during a pretest before use on a patient.Therefore, a new kit was used instead.

Event Description

It was reported that the user felt resistance when inserting the catheter into the epidural needle during a pretest before use on a patient.Therefore, a new kit was used instead.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported resistance was felt when inserting the catheter through the epidural needle.The customer returned one non-teleflex epidural needle w/wings and guard, and one epidural catheter w/thread assist (reference attached files inp1900075801).It should be noted, an epidural needle is not packaged with kit tu-05500-nron.The returned catheter was visually examined with and without magnification.Visual examination of the returned catheter revealed that the catheter appears typical with no defects or anomalies observed.The returned non-teleflex appeared typical as well.A dimensional inspection was performed on the returned epidural.The outer diameter (od) of the returned catheter measured 1.03mm (caliper c05155) which is within the specification of a maximum of 1.115mm per graphic kz-05400-030; rev 4.A dimensional inspection was performed on the returned non-teleflex epidural needle.Inner diameter (id) measurement of the returned needle revealed a value of 0.046" using pin gauges (ref-(b)(4).Which is typical for this type of needle.A functional test was performed by attempting to thread the returned catheter through the returned non-teleflex epidural needle.The catheter was thread at the distal end and would thread through the epidural needle with no resistance met.This was also performed using a lab inventory epidural needle with the same result.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.This was also performed using a lab inventory needle with the same results.The components passed the drag test.Specifications per graphic kz-05400-030; rev 4 was reviewed as a part of this complaint investigation.A design history review was performed kz-05400-030 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 no functional or dimensional issues could be found with the returned sample as the returned catheter threaded through the returned non-teleflex needle as well as a lab inventory needle with no issues.The reported complaint of resistance being felt when inserting the catheter into the needle could not be confirmed based on the sample received.The returned catheter could be thread through the returned non-teleflex needle as well as a lab inventory needle with no resistance met.The returned components passed a functional drag test, and the returned catheter od was found to be within specification as well as the returned needle id being typical.A device history record review was performed on the catheter with no relevant findings.Therefore, there were no issues found with the returned sample.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• MDR Report Key: 9884739
• MDR Text Key: 186730721
• Report Number: 3006425876-2020-00281
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• 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: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2021
• Device Catalogue Number: TU-05500-NRON
• Device Lot Number: 71F19L0359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Date Manufacturer Received: 04/21/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2019
• 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