MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT NRFIT

Catalog Number ASK-05500-NRON

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2020

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 rotatable collar of the filter was detached during use on a patient, and the medical agent leaked.Therefore, the catheter 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 units in a batch of 15,000.This is outside of the parameter for this defect.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed with a potentially relevant finding on the filter.However, the potential cause of this complaint could not be determined based upon the information provided and without the sample.

Event Description

It was reported that the rotatable collar of the filter was detached during use on a patient, and the medical agent leaked.Therefore, the catheter was removed and replaced with a new kit.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• MDR Report Key: 9991208
• MDR Text Key: 189153935
• Report Number: 3006425876-2020-00337
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2021
• Device Catalogue Number: ASK-05500-NRON
• Device Lot Number: 71F19K2042
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2019
• 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
• Treatment: N/A.