MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET: 19 GA; ANESTHESIA CONDUCTION CATHETER

Catalog Number EC-05400-E

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2018

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 resistance was met and excessive force was needed to administer anaesthetics.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported resistance was met when trying to inject medication through the catheter.The customer returned one snaplock a dapter 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 appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Adhesive can be seen on the outer extrusion and biological material can be seen within 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.No flow could be established out of the distal tip of the catheter.The test was repeated using the returned snaplock adapter 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 adapter.An attempt was made to thread a lab inventory wire through the epidural catheter from the proximal end.The wire threaded approximately 33.2cm (ga-ln-0560-002) from the proximal end of the returned catheter until an occlusion was found.The wire would not thread any further.An attempt was made to thread the lab inventory wire from the distal end.The wire threaded approximately 55.2cm before an occlusion was found.The wire would not thread any further.The catheter was cut opened at 33.2cm from the proximal end where the occlusion was discovered.Microscopic examination revealed a dried crystalline material.A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.All epidural catheters are water flow tested and air purged at the time of manufacturing.A device history record review performed on the epidural catheter showed no evidence to suggest a manufacturing related cause.The occlusion was detected during use.Therefore, root cause for this event could not be determined.The reported complaint of resistance was met when injecting medication through the catheter was confirmed based on the sample received.The returned epidural catheter was found to be completely occluded with material that appears to be a dried crystalline material.The material is present between the catheter's inner coils at approximately 33.2cm from the proximal tip.All epidural catheters are 100% water flow tested and air purged at the time of manufacturing.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.It is unknown how the catheter was handled prior to and during use.Therefore, the potential cause of the catheter being occluded could not be determined.

Event Description

It was reported that resistance was met and excessive force was needed to administer anaesthetics.

• Brand Name: EPIDURAL CATHETERIZATION SET: 19 GA
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8124648
• MDR Text Key: 129047687
• Report Number: 3006425876-2018-00780
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• 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: 11/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2019
• Device Catalogue Number: EC-05400-E
• Device Lot Number: 71F17L0841
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/03/2018
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 01/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1