MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC.; CONTINUOUS EPIDURAL ANESTHESIA TRAY

Catalog Number EPX475/118CJP

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/01/2018

Event Type  malfunction  

Event Description

It was reported that during the use of the product, the epidural catheter came off from the connector.No patient was reported.

Manufacturer Narrative

This mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.Brand name, unique identifier and 510k are unknown.No information has been provided to date.A device history record (dhr) review was not performed as the lot number was not available.A product sample was received for evaluation.Visual and functional testing were performed.Part of the catheter was connected to the connector.The catheter was cut at the point about 2 millimeter (mm) from the connector connection side, and the fracture surface had a trace like it was cut at the cutting edge.The root cause of the reported event was a possibility that it was accidentally cut with a cutter while using the product.The failure was a result of the customer/user interfacing with the product in a manner inconsistent with the information for use.No actions were taken for the primary concern reported.This event occurrence will be reported to the manufacturing site and recorded in the company's database.

Manufacturer Narrative

Other, other text: no same or similar product was sold in the us, it was sold only in japan., corrected data: please disregard the initial report submitted with the mfr number: 3012307300-2022-26126.The report was submitted in error.

• Type of Device: CONTINUOUS EPIDURAL ANESTHESIA TRAY
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): NULL; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15666441
• MDR Text Key: 306997917
• Report Number: 3012307300-2022-26124
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 10/28/2022

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 Catalogue Number: EPX475/118CJP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1