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

Catalog Number WJ-05401

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

It was another one that had been in 4 hours and stop working after that; was not able to flush at that point.

Manufacturer Narrative

Qn#(b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter was blocked.The customer returned one snaplock adapter and one epidural catheter.The components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock adapter revealed that the snaplock adapter typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears typical but used.Adhesive residue is present on the catheter body exterior and 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 (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 4.6ml/min (c05180), which is within the specification of 1ml/min.No blockages were found.The reported complaint of the catheter being blocked could not be confirmed based on the sample received.A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.During functional inspection, 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 another one that had been in 4 hours and stop working after that; was not able to flush at that point.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8386982
• MDR Text Key: 137715178
• Report Number: 1036844-2019-00203
• 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: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: WJ-05401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2019
• Date Manufacturer Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1