MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT NRFIT; Anesthesia conduction kit

Catalog Number ASK-05500-NRON

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/22/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.

Event Description

Medical agent was found leaking from the catheter during placement.Therefore, it was removed and replaced with a new one.

Event Description

Medical agent was found leaking from the catheter during placement.Therefore, it was removed and replaced with a new one.

Manufacturer Narrative

(b)(4).The customer reported the catheter was leaking.The customer returned one epidural catheter piece and lidstock.The returned catheter was visually examined with and without magnification.Visual examination of the returned catheter revealed part of the catheter is missing as the catheter appears to have been cut at the distal end.The catheter appears to have been used as biological material between the inner coils.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter piece using a ruler.The returned catheter extrusion measures approximately 15.0cm.This indicates at least 73.5cm of the extrusion is missing as the specification for the epidural catheter indicates that the proper extrusion length of an epidural catheter is 88.5-91.5cm.Functional inspection was performed on the returned sample.A functional leak test was performed using the returned catheter piece and a lab inventory snaplock assembly with the lab leak tester.The proximal end of the catheter was inserted into the snaplock assembly until it bottomed out and the components were locked.The catheter was confirmed to be secured by tugging gently.The snaplock assembly was then connected to the lab leak tester and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was then capped off and the pressure was increased to 25 psi for 30 seconds.A leak was detected coming from approximately 10.5cm from the proximal end.Microscopic examination revealed the catheter has a hole/cut.No other leaks were detected.Specifications per graphic were reviewed as a part of this complaint investigation.The ifu for this kit was reviewed as a part of this complaint investigation.The ifu cautions the user, "do not alter the catheter or any other kit/set component during insertion, use or removal (except as instructed)." in summary, the reported complaint of the catheter leaking was confirmed based on evaluation of the sample received.Visual and dimensional inspection revealed only 15cm of the catheter was returned as the catheter appeared to have been cut at the distal end.During the functional inspection, the returned epidural catheter was confirmed to leak at approximately 10.5cm from the proximal end where the catheter appears to be damaged.All epidural catheters are 100% tested for leaks at the time of manufacturing.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The leak was detected during use.Therefore, based on the time of discovery and the condition of the sample received, unintentional user error caused or contributed to this event.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• Type of Device: Anesthesia conduction kit
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15362813
• MDR Text Key: 300727927
• Report Number: 3006425876-2022-00790
• Device Sequence Number: 1
• Product Code: CAZ
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2023
• Device Catalogue Number: ASK-05500-NRON
• Device Lot Number: 71F20M1416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1