MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT NRFIT

Catalog Number TU-05500-NRON

Device Problem Separation Problem (4043)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2020

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.Therefore, the catheter was removed and replaced with a new kit.

Event Description

It was reported that the rotatable collar of the filter was detached during use on a patient.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 (b)(4) units in a batch of (b)(4).This is outside of the parameter for this defect.No relevant findings were found for the nrfit snaplock assembly or the epidural kit.The customer reported the rotatable collar detached from the collar.The customer returned one nrfit snaplock assembly and one nrfit flat filter (reference files (b)(4).The returned components were visually examined with and without magnification.Visual exanimation of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual inspection of the returned filter revealed the filter was received with the rotation collar detached from the filter.Microscopic examination of the male lock connection showed the lip that holds the collar in place is tapered.According to anesthesia r & d, the lip should be more of a 90deg angle at the top part of the lip to keep the collar from easily coming off.The customer also provided a video; however, the video is inoperable.The reported complaint of the rotating collar being detached from the filter was determined based on the sample received.Visual inspection of the returned filter revealed the rotation collar was detached from the male lock connector.Microscopic inspection revealed the lip that holds the collar was tapered and should be more of a 90deg angle to prevent the collar from easily coming off according to anesthesia r & d.A device history record review was performed with a potentially relevant finding on the filter.Therefore, the potential root cause of this issue is supplier related.A nonconformance has been initiated to further investigate this complaint issue.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• MDR Report Key: 9699431
• MDR Text Key: 183090084
• Report Number: 3006425876-2020-00171
• 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,u
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• 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: TU-05500-NRON
• Device Lot Number: 71F19K2043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Date Manufacturer Received: 03/20/2020
• 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