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

Catalog Number EC-05500

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Information (3190)

Event Date 01/18/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: the anesthesiologist placed the epidural but could not infuse through it.The patient's condition was reported as unknown.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the epidural catheter was not patent.The customer returned one epidural catheter and snaplock adapter with a non-teleflex flat filter.The components were received connected.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock revealed that the snaplock appears typical with no observed defects or anomalies, and revealed that the catheter appears used.Biological material was present between the catheter coils, especially at the distal tip which appeared to be filled with dried blood.Adhesive residue was present on the catheter body exterior).No other defects or anomalies were observed.A functional flow test was performed using the returned components and the lab leak tester (c05176).The catheter was confirmed to be secured to the snaplock adapter by tugging gently.The snaplock was then connected to the lab leak tester and the pressure was increased to 10 psi.No flow could be established to the catheter's distal end.The catheter is completely occluded.The test was other remarks: performed a second time using the returned snaplock adapter and a lab inventory epidural catheter (kz-05400-002).Flow could be established to the catheter's distal end, indicating that there are no functional issues with the returned snaplock adapter.A corrective action is not required at this time as the catheter was completely occluded with biological material.Based on the condition of the sample received, operational context caused or contributed to this event.The reported complaint of the catheter was not patent was confirmed based upon the sample received.Functional testing revealed the returned epidural catheter was completely occluded with biological material.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, based upon the damage observed and the time of discovery, operational context caused or contributed to this event.

Event Description

Alleged event: the anesthesiologist placed the epidural but could not infuse through it.The patient's condition was reported as unknown.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.A corrective action is not required at this time as the potential cause of inability to inject through the epidural catheter 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 with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of inability to inject through the epidural catheter could not be determined based upon the information provided and without a sample.Other remarks:.

Event Description

Alleged event: the anesthesiologist placed the epidural but could not infuse through it.The patient's condition was reported as unknown.

• Brand Name: EPIDURAL CATHETERIZATION COMPONENT
• 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5444494
• MDR Text Key: 38463624
• Report Number: 3006425876-2016-00041
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup,Followup
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: EC-05500
• Device Lot Number: 71F15H1772
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2015
• 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