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

Catalog Number JC-05400-B

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2018

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 physician placed the catheter normally.When he wanted to administrate drug, it was impossible to push the syringe contents through.After removal he tried again with the same result as the catheter had no distal hole.There was no patient injury.

Manufacturer Narrative

(b)(4).A device history record review could not be performed as a lot number was not provided by the customer.The customer reported they could not inject through the catheter.The customer returned one snaplock assembly and one epidural catheter.The components were received connected.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed that the snaplock appears 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 assembly until it bottomed out and the snaplock assembly was closed.The components were confirmed to be secured by tugging gently.The snaplock adapter was connected to the lab leak tester (c05176) 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 8.6ml/min (c05180), which is within the specification of 1ml/min.No blockages were found.The reported complaint of being unable to inject into the catheter could not be confirmed based on the sample received.The device history records were not reviewed as a lot number was not provided by the customer.The returned components passed a functional flow test and met flow rate specifications.There were no functional issues found with the returned sample.

Event Description

It was reported that the physician placed the catheter normally.When he wanted to administrate drug, it was impossible to push the syringe contents through.After removal he tried again with the same result as the catheter had no distal hole.There was no patient injury.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7964945
• MDR Text Key: 123877562
• Report Number: 3006425876-2018-00649
• 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: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JC-05400-B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2018
• Date Manufacturer Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1