MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

Catalog Number JC-05400-B

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

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 a triple incident occurred on (b)(6) 2019 in the maternity room.Three different doctors faced the same issue with devices from the same lot number.They had difficulties inserting the catheter in the tuohy needle because there was a blockage at the level of the distal bevel.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter and needle with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter and needle with no relevant findings.The potential cause of catheter not threading could not be determined based upon the information provided and without a sample.

Event Description

It was reported that a triple incident occurred on (b)(6) 2019 in the maternity room.Three different doctors faced the same issue with devices from the same lot number.They had difficulties inserting the catheter in the tuohy needle because there was a blockage at the level of the distal bevel.

Event Description

It was reported that a triple incident occurred on (b)(6) 2019 in the maternity room.Three different doctors faced the same issue with devices from the same lot number.They had difficulties inserting the catheter in the tuohy needle because there was a blockage at the level of the distal bevel.

Manufacturer Narrative

Qn#(b)(4).The customer reported the catheter had difficulty threading through the epidural needle.The customer returned one opened kit.The epidural needle and epidural catheter were removed from the kit and were visually examined with and without magnification.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.Visual examination of the returned catheter revealed that the catheter appears typical with no defects or anomalies observed.A dimensional inspection was performed on the returned epidural needle.Inner diameter (id) measurement of the returned needle revealed a value of 0.047" (1.1938mm) using pin gauges (c05157), which is within specification range of 1.119mm-1.22mm per graphic rz-05400006, rev 1.A dimensional inspection was performed on the returned epidural catheter.The outer diameter (od) of the returned catheter measured 1.04mm (caliper c05155) which is within the specification of a maximum of 1.115mm 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, rev 3 using the returned components 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 rz-054000-006, rev 1 and kz-005400-002; rev 9 were reviewed as a part of this complaint investigation.A design history review was performed for part # rz-054000-006 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 no functional or dimensional issues could be found with the returned sample as the returned catheter threaded through the returned needle with no issues.The reported complaint of the catheter being difficult to thread into the needle could not be confirmed based on the sample received.The returned catheter could be thread through the returned epidural 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 needle and catheter with no relevant findings.Therefore, there were no issues found with the returned sample.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8811982
• MDR Text Key: 151738301
• Report Number: 3006425876-2019-00518
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2021
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F19D1772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1