MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS; ANESTHESIA CONDUCTION KIT

Lot Number UNKNOWN

Device Problem Connection Problem (2900)

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

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

A product sample was received for evaluation.Visual inspection was performed.The actual flat filter and epidural connector were received in the connected state.The returned part of the collar mounting part was crushed.The timing of the collapse of the return part and the cause of the reported event could not be identified.Supplier reviewed their process of manufacturing a local anesthesia custom pack, and there was no abnormality such as damage or deformation before setting the flat filter on the tray.The root cause of reported issue could not be determined with the provided information.No product information has been provided to date.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

Event Description

It was reported that the collar got disconnected from the flat filter during the use of the product.No patient injury was reported.

• Brand Name: PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 15311471
• MDR Text Key: 305354117
• Report Number: 3012307300-2022-16515
• 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: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1