MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TRACHEOSTOMY

Model Number 101/860/080CZ

Device Problem Gel Leak (1267)

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

Event Date 06/01/2021

Event Type  malfunction  

Event Description

Information received a smiths medical tracheostomy|pvc - portex tubes bluselect had leaking.No patient injury was reported.

Manufacturer Narrative

Other, other text: investigation completed on a smiths medical bluselect 8.0, suctionaid, cuffed.Sub-assy was received for investigation without its original packaging.The manufacturing is reviewed and cuff passed 100 percent prior to leaving facility.The most like cause is believed incident occurred after leaving manufacturing and during placement.Each cuff shall be also tested by customer prior use as per instruction for use as10006183-004 rev.102, point 11.2: "check the integrity of the cuff and inflation system prior to insertion.".

Event Description

Device investigation completed and summary in h 10.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problems or issues were identified during this device history record review.A product sample was received for evaluation.Visual and functional testing were performed.It was found that it was not even possible to inflate cuff due to leaks.The root cause of the reported issue was found to be due to fact that cuff leak was observed after placement it is the most probable that reported failure occurred during tracheostomy procedure or during use.No actions were taken.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY
• 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; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 12086267
• MDR Text Key: 258983551
• Report Number: 3012307300-2021-06645
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076158
• UDI-Public: 15019517076158
• 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,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/080CZ
• Device Catalogue Number: 101/860/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Race: Asian