MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; DISPOSABLE ANESTHESIA BREATHING CIRCUITS

Model Number 450952-NL

Device Problem Disconnection (1171)

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

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

One sample was received in a unused condition inside it's closed original packaging.The sample was visually inspected at a distance of 12" under normal lighting to received unit, in order to detect any missing components and the reported issue was confirmed.The lot number of the reported device was not provided therefore no device history review (dhr) could be performed however; the confirmed issue is a known issue and was previously investigated in a manufacturing quality alert to prevent recurrence of the reported issued during the manufacturing process.Complaints trends will continue to be monitored.Operator of device and initial reporter also sent report to fda is unknown.No information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that during a pre-use check, the connector got detached from the breathing bag.No patient involvement.

• Brand Name: PORTEX
• Type of Device: DISPOSABLE ANESTHESIA BREATHING CIRCUITS
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-21-2 motohama-cho, naka-ku; minneapolis, MN 55442
• MDR Report Key: 15446809
• MDR Text Key: 306074504
• Report Number: 3012307300-2022-19657
• Device Sequence Number: 1
• Product Code: CAI
• UDI-Device Identifier: 15019315075834
• UDI-Public: 15019315075834
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K002506
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 450952-NL
• Device Catalogue Number: 450952-NL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2022
• 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