MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; N/A, NOT FOR US MARKET

Catalog Number JH-05500-J

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/10/2019

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 after placing the catheter in the patient, the user tried to inject medical agent, however, it did not flow.The catheter was replaced and the agent was injected without any problem.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported medical agent could not be injected into the catheter.The customer returned one snaplock adapter, one epidural catheter, and lidstock.The components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed that the snaplock assembly typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears typical but used.Biological material can be seen between the inner coils.No other defects or anomalies were observed.A functional flow test was performed on the returned sample per amrq-000017 section 7.8; rev.7.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 (c04552) and the pressure was increased to 10 psi to establish flow.Water could be seen immediately exiting the distal end of the catheter.The flow rate was measured at 8.4ml/min (c05180), which is within the specification of 1ml/min.No blockages were found.The reported complaint of being unable to inject medication into the catheter could not be confirmed based on the sample received.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The returned catheter passed a functional flow test and met flow rate specifications.There were no functional issues found with the returned catheter.

Event Description

It was reported that after placing the catheter in the patient, the user tried to inject medical agent, however, it did not flow.The catheter was replaced and the agent was injected without any problem.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: N/A, NOT FOR US MARKET
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8275672
• MDR Text Key: 134310769
• Report Number: 3006425876-2019-00056
• 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: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• 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: JH-05500-J
• Device Lot Number: 71F18B0839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1