MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SETS

Catalog Number CA-02220

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2018

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 epidural catheter would not flush and there was resistance when the doctor tried to inject a test dose into patient.The epidural catheter had to be removed, a new epidural tray opened and procedure re-done.When the doctor attempted to flush epidural catheter once it was removed, the catheter was not able to be flushed.The was no patient injury.

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 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.

Event Description

It was reported that the epidural catheter would not flush and there was resistance when the doctor tried to inject a test dose into patient.The epidural catheter had to be removed, a new epidural tray opened and procedure re-done.When the doctor attempted to flush epidural catheter once it was removed, the catheter was not able to be flushed.The was no patient injury.

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 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.

Event Description

It was reported that the epidural catheter would not flush and there was resistance when the doctor tried to inject a test dose into patient.The epidural catheter had to be removed, a new epidural tray opened and procedure re-done.When the doctor attempted to flush epidural catheter once it was removed, the catheter was not able to be flushed.The was no patient injury.

• Brand Name: EPIDURAL CATHETERIZATION SETS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7498863
• MDR Text Key: 108347754
• Report Number: 1036844-2018-00125
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: CA-02220
• Device Lot Number: 13F17M0221
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1