MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

Catalog Number ASK-05500-KM

Device Problem Difficult to Flush (1251)

Patient Problem No Patient Involvement (2645)

Event Date 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (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 user was unable to flow saline into the catheter with syringe during a flushing test.Therefore, it was replaced with a new kit.

Event Description

It was reported that the user was unable to flow saline into the catheter with syringe during a flushing test.Therefore, it was replaced with a new kit.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter would not flush.The customer returned one 5ml syringe, one snaplock assembly, an epidural catheter, and lidstock.The returned snaplock assembly and catheter were received connected together (reference files (b)(4).The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Biological material can be seen between the inner coils.There is a heavy presence of biological material at the distal end of the returned catheter.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 assembly was connected to the lab leak tester (ref-002902) and the pressure was increased to 10 psi to establish flow.No flow could be established out of the distal tip of the catheter.The test was repeated using the returned snaplock assembly and lab inventory epidural catheter.Flow could be established to the distal tip of the catheter, indicating that there are no flow issues with the returned snaplock assembly.An attempt was made to thread a lab inventory wire through the epidural catheter from the proximal end.The wire threaded approximately 39.1cm (10171599) from the proximal end of the returned catheter until an occlusion was found.An attempt was made to thread a lab inventory wire through the epidural catheter from the distal end.The wire threaded approximately 23.0cm from the distal end of the returned catheter until an occlusion was found.Microscopic examination where the catheter was blocked indicated biological material is present between the catheter's inner coils.The wire was able to push the occlusion on through the catheter.A flow test was once again performed with the returned catheter and returned snaplock assembly.Flow was established coming from the distal tip.However, the initial flow was reddish material that was pushed through and the flow became clear indicating biological material present in the catheter was causing the occlusion (reference files (b)(4).The flow rate was measured at 7.8ml/min (c05180), which is within the specification of 1ml/min.A corrective action is not required at this time as the condition of the sample received indicates unintentional user error caused or contributed to this event.The reported complaint of catheter not being able to flush was confirmed during functional inspection of the returned sample.The returned epidural catheter was found to be completely occluded with biological material.Microscopic examination where the catheter was blocked indicated biological material is present between the catheter's inner coils at approximately 39.1cm from the proximal end and 23.0cm from the distal end.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, based upon the condition of the sample received, unintentional user error caused or contributed to this event.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 9722965
• MDR Text Key: 180328659
• Report Number: 3006425876-2020-00197
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: ASK-05500-KM
• Device Lot Number: 71F19F0005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Date Manufacturer Received: 03/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1