MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT NRFIT

Catalog Number ASK-05500-NRON

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/28/2021

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

The rotatable collar of the filter got detached during use on a patient.Therefore, the catheter was removed and replaced with a new kit.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the flat filter with no relevant findings.The customer reported the rotating collar of the filter got detached during use.The customer returned one flat filter nrfit, one snaplock assembly nrfit, and epidural catheter.The returned filter was received with the rotation collar attached to the male lock connector.The returned sample was visually examined with and without magnification.Visual examination of the returned filter and snaplock revealed both appear typical with no observed defects or anomalies.Visual examination of the returned epidural catheter revealed that the catheter appears used.Biological material can be seen between the catheter coils.No other defects or anomalies were observed.Functional inspection was performed on the returned sample.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.An attempt to remove the rotating collar from the male lock connector of the returned filter was performed.Using hand pressure, the rotating collar could not be removed even with much effort.A corrective action is not required at this time as there were no functional issues found with the returned sample.The reported complaint of the rotating collar detaching from the filter could not be confirmed based on the sample received.Visual inspection of the returned filter revealed the rotating collar was attached to the male lock connector.Using hand pressure, the returned filter's collar could not be removed from the male lock connector even with much effort.Also, there were no connection issues when connecting the rotating collar using hand pressure to the returned snaplock assembly.A device history record review was performed on the flat filter with no relevant findings.Based on the functional testing, there was no issues found with the returned sample.No further action is required at this time.

Event Description

The rotatable collar of the filter got detached during use on a patient.Therefore, the catheter was removed and replaced with a new kit.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• MDR Report Key: 12020456
• MDR Text Key: 260097143
• Report Number: 3006425876-2021-00553
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2022
• Device Catalogue Number: ASK-05500-NRON
• Device Lot Number: 71F20L0376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Date Manufacturer Received: 07/13/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2020
• 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