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

Model Number 100/810/080

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Abrasion (1689)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

The lot number is yet to be confirmed.

Event Description

Information was received indicating that a patient was admitted for cerebral hemorrhage.The patient underwent a right frontotemporal craniectomy decompression, a microscope removal of intermandibular hematoma and a tracheostomy using the portex tubes blue line ultra (blu).Bloody secretions were noted in the cannula.The doctor was asked to perform a fiberoptic bronchoscopy.It was found that the tracheotomy cannula rubbed the airway mucosa causing the mucosal bleeding.

Manufacturer Narrative

Other, other text: testing/inspection.No product was returned.It was unable to confirm the reported complaint.If the product is returned smiths medical will reopen this complaint for further investigation.Other analysis no other analysis was performed.Mitigation: mp trachy blu-tj100 rev.008 blu/blus tracheostomy tubes manufacturing.Qp trachy blu-tj rev.106 trachy blue line assembly and packaging.Rmp 1031 rev.001 risk management plan summary for blue line ultra / blue line ultra suction aid tracheostomy.Occurrence: cuff evacuation unit and fixture for place trachy tubes and following the procedure mp trachy blu-tj110 blu /blus tracheostomy tube - deflate and inspect.Detection: production personnel performs a 100% inflation test and visual inspection.Quality inspectors takes a representative sample of the lot ensure that cuff is properly inflation.Quality visually inspects cannula can pass freely into and out of the tube and clip securely into place aql 1.0/g-i during prepackaging quality inspects cannula o.D is equal to tracheostomy tube i.D using visual aid pwi-10008027 as a reference aql 1.0/g-i root cause: customer reported: (from china medical device adverse event monitoring information system) the patient was admitted to our department for "cerebral hemorrhage", and in (b)(6) 2020 was given "right frontotemporal craniectomy decompression + microscope removal of intermandibular hematoma + tracheostomy".On (b)(6) 2020 there was bloody secretion in the tracheotomy cannula.On (b)(6) 2020, the infected doctor was asked to perform a fiberoptic bronchoscopy.It was found that the tracheotomy cannula rubbed the airway mucosa to the mucosal bleeding.No root cause could be determined since the complaint was not confirmed due to the fact that no samples or pictures were received to perform a thorough investigation.Action taken: no corrective actions are required since the complaint was not confirmed.

Event Description

Sme signed off on the investigation.No product returned.A summary of engineering practices.

• Brand Name: PORTEX
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11042578
• MDR Text Key: 222615571
• Report Number: 3012307300-2020-12595
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 100/810/080
• Device Lot Number: 3689099
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/19/2020
• Supplement Dates Manufacturer Received: 04/26/2026
• Supplement Dates FDA Received: 05/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening