MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA CIRCUITS; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number 100/133/065

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 03/31/2022

Event Type  Injury  

Event Description

It was reported that the cuff was punctured.After a few minutes, the cuff leaked.Cuff tested after removal with water, 2 to 3 holes.The customer confirmed that no consequence clinical was observed.

Manufacturer Narrative

This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.A product sample was received for evaluation.Visual testing was performed.The sample was received in used condition without original package.Rips in cuff was detected, the complaint was confirmed.Based on the analysis conducted in the sample provided, the root cause is addressed to cuff damaged during intubation.No corrective action is required due to no failure during the pre-checked was confirmed.

• Brand Name: PORTEX GENERAL ANESTHESIA CIRCUITS
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14375819
• MDR Text Key: 291514546
• Report Number: 3012307300-2022-08650
• Device Sequence Number: 1
• Product Code: BTR
• UDI-Device Identifier: 15019315020346
• UDI-Public: 15019315020346
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K931735
• 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,Followup
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100/133/065
• Device Catalogue Number: 100/133/065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2023
• 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
• Patient Outcome(s): Required Intervention