MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT NRFIT

Catalog Number TU-05500-NRON

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2020

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 catheter was inserted into the patient on (b)(6) and an epidural anesthetic was given safely during an operation next day.On (b)(6) solution was found leaking from the catheter in the ward, and it was confirmed that the catheter was almost fractured.It was about 23cm from the tip the part that was fixed by tegaderm.

Event Description

It was reported that the catheter was inserted into the patient on (b)(6) , and an epidural anesthetic was given safely during an operation next day.On (b)(6) , solution was found leaking from the catheter in the ward, and it was confirmed that the catheter was almost fractured.It was about 23cm from the tip the part that was fixed by tegaderm.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed based upon a potential lot number.A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter was leaking.The customer returned 10ml injection syringe, one flat filter nrfit, one snaplock assembly nrfit, and one epidural catheter.The returned snaplock assembly and catheter were received connected together (reference attached files inp1900077942).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 biological material can be seen on the inner coils and adhesive can be seen on the outer extrusion.Microscopic examination of the catheter revealed the catheter is damaged at approximately 24.8 (ruler: 10171599) from the distal end.The extrusion appears to have a hole.No other damage was observed.Functional inspection was performed on the returned sample.A functional leak test was performed per amrq-000017 section 7.5 rev.7 using the returned catheter and snaplock assembly with the lab leak tester (ref-002902).The proximal end of the catheter was inserted into the snaplock assembly until it bottomed out and the components were locked.The catheter was confirmed to be secured by tugging gently.The snaplock assembly was then connected to the lab leak tester and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was then capped off and the pressure was increased to 25 psi for 30 seconds.A leak was detected coming from the same location where the catheter has a hole at 24.8cm from the distal end, which was revealed during the visual inspection.No other leaks were detected.A corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.All epidural catheters are tested for leaks at the time of manufacturing.A device history record review performed on the epidural catheter showed no evidence to suggest a manufacturing related cause.The leak was detected during use.Therefore, based on the condition of the sample received and the time of discovery indicate unintentional user error caused or contributed to this event.The reported complaint of the catheter leaking was confirmed based on the sample received.During the functional inspection, the returned epidural catheter was confirmed to leak from where the catheter was damaged at approximately 24.8cm from the distal end.All epidural catheters are 100% tested for leaks at the time of manufacturing.A device history record review was performed based upon a potential lot number.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The leak was detected during use.Therefore, based on the time of discovery and the condition of the sample received, unintentional user error caused or contributed to this event.

• Brand Name: EPIDURAL CATHETERIZATION KIT NRFIT
• MDR Report Key: 10325970
• MDR Text Key: 202032826
• Report Number: 3006425876-2020-00651
• 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: 07/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TU-05500-NRON
• Device Lot Number: 71F19L0359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Date Manufacturer Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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