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

Catalog Number TU-05500-NRO

Device Problem Fluid/Blood Leak (1250)

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

Event Date 03/13/2023

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

Reported issue: the medical agent was found leaking from the connection part of the filter and the snaplock adapter about three days after placement of the catheter.The connection was not loose, but the medical agent leaked enough to soak into the gauze.Therefore, the catheter was removed and replaced with a new one.No injury to the patient occurred.

Manufacturer Narrative

(b)(4).The customer reported there was a leak from the connection between the filter and the snaplock.The customer returned one flat filter nrfit, one snaplock assembly nrfit, and an epidural catheter.The returned components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned flat filter and snaplock assembly revealed both components appear typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears used as biological material can be seen on the inner coils and adhesive can be seen on the outer extrusion.No other defects or anomalies were observed.A functional leak test was performed on the returned sample using the returned components with the lab leak tester.The returned flat filter was connected to the returned snaplock assembly by connecting the male lock connecter to the returned snaplock assembly by hand tightening the rotating collar.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 flat filter was connected to the lab leak tester and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was capped off and the pressure was increased to 25 psi for 30 seconds.No leak was observed.A device history record review was performed on the snaplock assembly with no relevant findings.The reported complaint of a leak from the connection between the filter and the snaplock could not be confirmed based on the sample received.The returned components were functionally leak tested with no leaks observed.A device history record review was performed on the snaplock assembly with no evidence to indicate a manufacturing related issue.Based on the functional testing, there were no issues found with the returned sample.No further action is required at this time.

Event Description

Reported issue: the medical agent was found leaking from the connection part of the filter and the snaplock adapter about three days after placement of the catheter.The connection was not loose, but the medical agent leaked enough to soak into the gauze.Therefore, the catheter was removed and replaced with a new one.No injury to the patient occurred.

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT NRFIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16640300
• MDR Text Key: 312283420
• Report Number: 3011137372-2023-00087
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

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 Expiration Date: 05/31/2023
• Device Catalogue Number: TU-05500-NRO
• Device Lot Number: 71F21J0890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 05/02/2023
• Supplement Dates FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2021
• 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
• Treatment: NONE REPORTED; NONE REPORTED