MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET NRFIT

Catalog Number EJ-05400-NRON

Device Problem Product Quality Problem (1506)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

The user reported that the drape was found to be caught between the lidstock and the tray upon opening the kit.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural kit with no relevant findings.The customer reported the drape was found in between the tray and listock upon opening the kit.The customer returned an empty kit only consisting of the outer tray and lidstock.The returned sample was visually examined with and without magnification.Visual examination revealed the outer tray appears to have missing adhesive on the right side of the tray lip approximately 10cm (10171599) from the bottom of the tray.Visual examination of the lidstock revealed an impression at the same location where the lidstock would seal to the outer tray.No other defects or anomalies were observed.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 the condition of the sample received.Since the contents of the kit were not sent back in the form on which the drape was discovered, it cannot be determined if the missing adhesive on the tray is due to the drape being in between the tray and lidstock or if the adhesive was retained on the lidstock itself.The reported complaint of the drape being found between the outer tray and lidstock could not be confirmed based on the sample received.Only the outer tray and lidstock were returned.During visual inspection, it was revealed the outer tray appeared to have missing adhesive on the right side of the tray lip approximately 10cm from the bottom of the tray.Visual examination of the lidstock also revealed an impression at the same location where the lidstock would seal to the outer tray.A device history record review was performed on the epidural kit with no evidence to suggest a manufacturing related issue.Since the contents of the kit were not sent back in the form on which the drape was discovered, it cannot be determined if the missing adhesive on the tray is due to the drape being in between the tray and lidstock or if the adhesive was retained on the lidstock itself.Therefore, the potential cause of this complaint could not be determined.

Event Description

The user reported that the drape was found to be caught between the lidstock and the tray upon opening the kit.

• Brand Name: EPIDURAL CATHETERIZATION SET NRFIT
• MDR Report Key: 10152680
• MDR Text Key: 195717152
• Report Number: 3006425876-2020-00505
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2022
• Device Catalogue Number: EJ-05400-NRON
• Device Lot Number: 71F20A1819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Date Manufacturer Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2020
• 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