MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET: 19 GA; CATHETER, PERCUTANEOUS

Catalog Number EC-05400-E

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2018

Event Type  Injury  

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 epidural catheter placement was difficult but atraumatic.The catheter was unable to be injected.After assessing the situation, troubleshooting both the process and equipment as well as manipulating the catheter it was removed.A second catheter was placed and injected normally.Post care the first catheter was reviewed.After multiple high pressure attempts to inject the catheter a small piece of string like plastic material came from the distal opening of the catheter.There were no kinks cuts or other visible disruptions to the catheter.There was no patient injury.

Event Description

It was reported that the epidural catheter placement was difficult but atraumatic.The catheter was unable to be injected.After assessing the situation, troubleshooting both the process and equipment as well as manipulating the catheter it was removed.A second catheter was placed and injected normally.Post care the first catheter was reviewed.After multiple high pressure attempts to inject the catheter a small piece of string like plastic material came from the distal opening of the catheter.There were no kinks cuts or other visible disruptions to the catheter.There was no patient injury.

Manufacturer Narrative

Qn#(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 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 with no evidence to suggest a manufacturing related cause.The potential cause of the catheter being blocked could not be determined based upon the information provided and without a sample.

• Brand Name: EPIDURAL CATHETERIZATION SET: 19 GA
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7713766
• MDR Text Key: 114826263
• Report Number: 3006425876-2018-00513
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: EC-05400-E
• Device Lot Number: 14F18D0261
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/17/2018
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: 09/04/2018
• Supplement Dates FDA Received: 09/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1