MAUDE Adverse Event Report: SMITHS MEDICAL CZECH REPUBLIC A. S EPIDURAL CATHETER, LATERAL EYES, CLEAR; ANESTHESIA CONDUCTION KIT

Catalog Number 100/382/118CZ

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/03/2023

Event Type  Injury  

Event Description

It was reported that a noise was heard while moving the epidural catheter.When removing the product, it was noticed that a few millimeters of the catheter did not come out.As a result, the patient required medical intervention to remove the broken catheter.There was no patient harm reported.

Manufacturer Narrative

D5.Other operator of device: operator of device is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation summary: the investigation of the complaint was limited because no sample was returned.During manufacturing each catheter is visually inspected and checked under magnification, as well as functionally tested on flow meter.Detection mechanisms are in place, and it is improbable that the catheter -- which is cut or partially cut -- would pass through those inspections.It is probable that the failure was caused by the customer due to incorrect practice, but with the lack of samples or more information, the root cause of this failure remains unknown.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: EPIDURAL CATHETER, LATERAL EYES, CLEAR
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL CZECH REPUBLIC A. S; olomoucká 306; hranice 753 0 1; EZ 753 01
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18759753
• MDR Text Key: 336011299
• Report Number: 3011237704-2024-00044
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 100/382/118CZ
• Device Lot Number: 4087835
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention