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

Catalog Number OU-05500-J

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter and snaplock adapter with no relevant findings.The customer reported the catheter disconnected from the snaplock adapter.The customer returned one snaplock adapter with clamp, one flat filter, and one epidural catheter ((b)(4)).The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned flat filter revealed that the filter appears typical with no observed defects or anomalies.Visual examination of the returned epidural catheter revealed that the catheter appears used.Biological material can be seen between the catheter coils and adhesive residue is present on the catheter body exterior.Also, the coils appear to be offset at approximately 40mm ((b)(4)) from the proximal and the catheter was in a knot at approximately 50mm from the proximal end.No other defects or anomalies were observed.Other remarks: a functional leak test was performed on the returned sample per mrq (b)(4).The returned epidural catheter was inserted from the proximal end into the returned snaplock adapter until it bottomed out and the snaplock adapter was closed.The components were confirmed to be secured by tugging gently.The snaplock adapter was connected to the lab leak tester ((b)(4)) and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was capped off and the pressure was increased to 25 psi for 30 seconds.A leak was detected coming from the catheter at approximately 20.5cm from the distal end; however, the components remained secured.Microscopic examination of the returned catheter indicated a cut in the extrusion at that location.It should be noted this does not impact the functionality of the snaplock adapter and epidural catheter connection and therefore, is not relevant to the reported complaint issue.A functional spo test was then performed per mrq (b)(4).The proximal end of the epidural catheter was re-inserted into the snaplock adapter until it bottomed out and the snaplock adapter was locked.The components were confirmed to be secured by tugging gently on the catheter.The components were then left to sit for 72 hours in the locked position.After 72 hours, the snaplock adapter was confirmed to have remained securely locked with the catheter inserted.No functional connection issues were found with the returned snaplock adapter and catheter.

Event Description

Alleged event: the catheter was successfully inserted and the snaplock adapter could be closed.However, the catheter came off the snaplock adapter easily even though the user was using the white clip for securing the catheter.As a result, the inserted catheter was removed and a new one was inserted.The patient's condition was reported as fine.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 5580929
• MDR Text Key: 42783755
• Report Number: 3006425876-2016-00069
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: OU-05500-J
• Device Lot Number: 71F15H0296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2015
• 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
• Patient Outcome(s): Required Intervention