MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET NRFIT

Catalog Number EJ-05400-NRON

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (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 the user was unable to connect the filter to a pump as the connector of the filter was loose.Therefore, the catheter and filter was removed and replaced with a new kit.

Manufacturer Narrative

(b)(4).A device history record review was performed with a potentially relevant finding.For material # s-02200-003n (flat filter), lot # 23p17e0431, according to incoming inspection records, the rotating collar popped off 3 of 315 pc sample size during inspection.This is outside of the parameter for this defect.The customer reported the filter was unable to connect to a pump because the connection was loose.The customer returned one snaplock assembly nr fit, one flat filter nr fit, and catheter.The components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned filter and snaplock assembly revealed they both appear typical with no observed defects or anomalies.Visual examination of the returned catheter revealed that the catheter appears used as adhesive can be seen on the outer extrusion.No other defects or anomalies were observed.Functional inspection was performed on the returned filter.A lab inventory glass lor syringe was connected to the female lock connector of the returned filter with no issue.Then the returned snaplock assembly was connected to the male lock connector of the returned filter and hand tightening the rotating collar to the snaplock assembly with no issues.A manual leak test was performed on the components with the returned epidural catheter and a closed snaplock adapter.Water was injected into the filter and no leaks were observed.A corrective action is not required at this time as no issues were found with the returned sample.The reported complaint of the filter having connection issues could not be determined based on the sample received.During functional inspection, both ends of the returned filter connected to a lor syringe and snaplock assembly respectively with no issues.Also, no leaks were observed during a manual leak test.A device history record review was performed with a potentially relevant finding on the filter.However, no issues were found with the returned sample.

Event Description

It was reported that the user was unable to connect the filter to a pump as the connector of the filter was loose.Therefore, the catheter and filter was removed and replaced with a new kit.

• Brand Name: EPIDURAL CATHETERIZATION SET NRFIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10066182
• MDR Text Key: 191668918
• Report Number: 3006425876-2020-00432
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2021
• Device Catalogue Number: EJ-05400-NRON
• Device Lot Number: 71F19J0604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Date Manufacturer Received: 06/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1