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

Model Number 101/860/085CZ

Device Problem Leak/Splash (1354)

Patient Problem Pneumonia (2011)

Event Date 10/01/2021

Event Type  Injury  

Event Description

The customer started using the product for regular replacement for a patient with encephalitis.On oct/21, the customer noticed the pilot balloon was detached from the inflation line and he changed the product to another new one.In the morning of oct/22, the patient suffered pneumonia and was undergoing medical treatment (pneumonia was caused by secretion that went into the lung(s)).No further adverse patient effects were reported.

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.The returned sample was visually inspected at 12in to 16in and normal conditions of illumination according site visual inspection procedure.Inflation line detached from pilot balloon was observed and a lack of solvent was detected.The root cause of the reported issue was found to be not enough solvent at joint cause by bad condition on the feeder system equipment.Actions were taken to mitigate the reported issue: a nonconforming report (ncr)was opened, as well where implemented immediate actions to mitigate this reported condition by improving process steps direct related with factors in process.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY TUBE
• 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: 12808240
• MDR Text Key: 280763021
• Report Number: 3012307300-2021-11183
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076165
• UDI-Public: 15019517076165
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 101/860/085CZ
• Device Catalogue Number: 101/860/085CZ
• Device Lot Number: 4110784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/22/2021
• 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
• Patient Outcome(s): Required Intervention