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

Catalog Number 100/391/118CZ

Device Problem Break (1069)

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

Event Date 08/04/2020

Event Type  malfunction  

Event Description

It was reported that the connector broke.No patient injury was reported.

Manufacturer Narrative

A device history record review was performed and indicated a design issue was identified.A product sample was received for evaluation.The reported connector was not present.A photo provided with the complaint was inspected and shows a broken hinge.Unable to determine the root cause of the reported issue.This issue is monitored by pattern trend analysis and corrective actions (if any) will be implemented.Based on 200,000 uses per year it will take 20 complaints to increase the risk level to moderate.The proposed threshold will allow for review before the risk level increases.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: PORTEX
• 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; minneapolis, MN 55442
• MDR Report Key: 15401799
• MDR Text Key: 306161283
• Report Number: 3012307300-2022-18653
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K172410
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/391/118CZ
• Device Lot Number: 3869447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/26/2022
• 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