MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

Model Number IPN919630

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that "an anesthesia provider put an epidural in a ob patient on sunday and the catheter would not flush.He tried to troubleshoot it and replace the syringe snaplock but end up replacing the whole catheter.Even when he took it out of the patient he still couldn't get it to flush".No patient harm or injury.The patient status is reported as "ok".

Event Description

It was reported that "an anesthesia provider put an epidural in a ob patient on sunday and the catheter would not flush.He tried to troubleshoot it and replace the syringe snaplock but end up replacing the whole catheter.Even when he took it out of the patient he still couldn't get it to flush".No patient harm or injury.The patient status is reported as "ok.".

Manufacturer Narrative

Qn# (b)(4).The customer returned one epidural catheter.The returned catheter was visually examined with and without magnification.Visual examination of the returned catheter revealed the catheter appears used.Biological material can be seen between the inner coils especially at the distal end of the returned catheter.No other defects or anomalies were observed.The customer also provided a photo that appear to show a separated epidural catheter.A functional flow test was performed on the returned sample.The returned epidural catheter was inserted from the proximal end into the lab inventory 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 and the pressure was increased to 10 psi to establish flow.No flow could be established out of the distal tip of the catheter.An attempt was made to thread a lab inventory wire through the epidural catheter from the proximal end.The wire threaded approximately 76.2cm from the proximal end of the returned catheter until an occlusion was found.The wire was able to push the occlusion on through the catheter.A flow test was once again performed with the returned catheter and lab inventory snaplock assembly.Flow was est ablished coming from the distal tip.The flow rate was measured at 8.2ml/min, which is within the specification of 1ml/min.The reported complaint of the catheter not flushing was confirmed during functional inspection of the returned sample.The returned epidural catheter was found to be completely occluded possibly with biological material.Microscopic examination where the catheter was blocked indicated biological material was present between the catheter's inner coils at the distal end of the returned catheter.The root cause of the issue could not be determined based on the condition of the returned sample.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16819178
• MDR Text Key: 314053320
• Report Number: 1036844-2023-00034
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902189315
• UDI-Public: 10801902189315
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2023

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 Model Number: IPN919630
• Device Catalogue Number: SJ-05501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1