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

Catalog Number EJ-05400-NRO

Device Problem Disconnection (1171)

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

Event Date 09/28/2022

Event Type  malfunction  

Event Description

T was reported that 2 days after placement of the catheter, a leak was found.On checking, a nurse found that the catheter was completely disconnected from the snaplock adapter.Therefore, the catheter and the snaplock adapter were replaced with a new kit.According to the md, it was expected that some tension was applied due to the weight of the connected pca pump, but he/she confirmed that the snaplock adapter was locked to the end.

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Manufacturer Narrative

Qn#(b)(4).According to the engineer investigating the reported device failure, the customer reported that the snaplock assembly disconnected from the catheter.The customer returned one snaplock assembly nrfit and epidural catheter.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no defects or anomalies observed.Visual examination of the returned epidural catheter revealed the catheter appears used.Biological material can be seen between the catheter coils and adhesive residue is present on the catheter body exterior.No other defects or anomalies were observed.A functional leak test was performed on the returned snaplock assembly and epidural catheter.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 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 leaks were detected, and the components remained secured.A functional spontaneous partial opening (spo) test was then performed.The proximal end of the epidural catheter was re-inserted into the snaplock assembly until it bottomed out and the snaplock assembly was locked.The components were confirmed to be secured by tugging gently on the catheter.The components were then left to sit for 72 hours in the locked position.After 72 hours, the snaplock assembly was confirmed to have remained securely locked with the catheter inserted.No functional issues were found.In summary, the reported complaint of the snaplock assembly disconnecting from the catheter could not be confirmed through functional testing of the returned snaplock assembly.The snaplock assembly was secured to the returned epidural catheter and passed the functional tests performed including a spontaneous partial opening (spo) test.A device history record review was performed on the epidural catheter and snaplock assembly with no relevant findings.The investigation found no evidence to suggest a manufacturing related cause.Therefore, based on functional testing of the returned sample, no problem was found with the returned sample.No further action is required at this time.

Event Description

It was reported that 2 days after placement of the catheter, a leak was found.On checking, a nurse found that the catheter was completely disconnected from the snaplock adapter.Therefore, the catheter and the snaplock adapter were replaced with a new kit.According to the md, it was expected that some tension was applied due to the weight of the connected pca pump, but he/she confirmed that the snaplock adapter was locked to the end.

• Brand Name: EPIDURAL CATHETERIZATION SET 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: 15550318
• MDR Text Key: 301255248
• Report Number: 3006425876-2022-00904
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: EJ-05400-NRO
• Device Lot Number: 71F21K1526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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