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

Catalog Number JC-05400-B

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2019

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 the apd catheter cannot advance in the epidural zone. A new kit was opened.

Event Description

It was reported that the apd catheter cannot advance in the epidural zone. A new kit was opened.

Manufacturer Narrative

Qn#(b)(4). A device history record review was performed on the epidural catheter and needle with no relevant findings. The customer reported the catheter was difficult to advance. The customer returned one epidural catheter and lidstock. No needle was returned. The returned catheter was visually examined with and without magnification. Visual examination of the returned epidural catheter revealed that the catheter appears typical with no defects or anomalies observed. The outer diameter (od) of the returned catheter measured 1. 05mm (caliper c05155) which is within the specification of a maximum of 1. 115mm per graphic kz-05400-002; rev 9. An attempt to thread the returned epidural catheter was made. The distal end of the catheter would thread through a lab inventory 17ga needle with no resistance met. A drag test was performed per pip-013, rev. 3 using the returned catheter, a lab inventory needle and weight (c05406). The catheter passed the drag test with the lab inventory needle. Specifications per graphic kz-05400-002; rev. 9 was reviewed as a part of this complaint investigation. A design history review was performed for part # rz-05400-006 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 the root cause could not be determined. The reported complaint of the catheter being difficult to advance could not be confirmed based on the sample received. The customer returned a catheter , but no needle was returned. The returned epidural catheter could be thread through a 17ga lab inventory needle with no resistance met. The returned catheter also passed a functional drag test and the returned catheter od was found to be within specification. A device history record review was performed on the epidural catheter and needle with no relevant findings. The catheter is an interactive part. Therefore, based upon the condition of the sample received, the information provided, and the fact the needle was not returned, the potential cause of this complaint could not be determined.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9172940
• MDR Text Key: 161736766
• Report Number: 3006425876-2019-00766
• 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: 09/20/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/26/2021
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F19F0256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No