MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. CONTINUOUS EPIDURAL ANESTHESIA TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number A4219-17

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 05/30/2019

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Unique identifier and g5 510k are unknown.No information has been provided to date.A device history record (dhr) review was performed, and no discrepancies were found or anomalies relevant to the complaint.A product sample was received for evaluation.Visual and functional testing were performed.A plastic bag containing two used and decontaminated epidural catheters, two epidural catheter connectors and a non-manufacture device which included tubing and assorted adapters.No original packaging was present.Visual inspection revealed that the catheters and connectors were not assembled.The connectors were in the fully engaged position (closed) upon receipt.A review of the manufacturing process for was conducted by quality engineer in order to verify that there are no situations or practices that could create the event.No discrepancies were found.Both assemblies failed to remain assembled when tested with 5n weight (specification remained assembled for 2 minutes minimum).Actual time at failure, 17 seconds and 23 seconds.While consideration may be made to account for the condition of the used samples prior to testing, the separation of the components confirmed the complaint.The root cause of the reported issue could not be determined as a result of this investigation.No action was taken.Complaint information will continue to be monitored for any new information or adverse trends and further actions will be taken accordingly.As manufacturing continue monitoring for other reports and obtaining new information, manufacturing will expand their investigation beyond this specific complaint to include the evaluation of our raw material and finished goods stock.

Event Description

It was reported that the epidural catheter disconnected from the yellow connection port.No patient injury was reported.

• Brand Name: CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15671290
• MDR Text Key: 302858461
• Report Number: 3012307300-2022-26227
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2021
• Device Catalogue Number: A4219-17
• Device Lot Number: 3799375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1