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

Catalog Number TU-05500-NRO

Device Problem No Flow (2991)

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

Event Date 09/06/2022

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

It was reported that the medical agent did not flow through the catheter.Therefore, the catheter was removed and replaced with a new one.

Manufacturer Narrative

(b)(4).The customer reported the catheter would not inject medication.The customer returned one snaplock assembly nrfit and lidstock.No epidural catheter was returned).The returned sample was visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.A functional flow test was performed on the returned snaplock assembly.A lab inventory 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.Water could be seen immediately exiting the distal end of the catheter.The flow rate was measured at 8.2ml/min, which is within the specification of 1ml/min minimum.No blockages were found.In summary, the reported complaint of the catheter not injecting medication could not be confirmed based on the sample received.No epidural catheter was returned, only a snaplock assembly.The returned snaplock assembly passed a functional flow test and met flow rate specifications.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.Therefore, based on this, this complaint investigation could not be determined based upon the information provided and the sample received.No further action is required at this time.

Event Description

It was reported that the medical agent did not flow through the catheter.Therefore, the catheter was removed and replaced with a new one.

• 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: 15641390
• MDR Text Key: 302570606
• Report Number: 3006425876-2022-00842
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TU-05500-NRO
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: No
• 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