MAUDE Adverse Event Report: PORTEX; TRACHEOSTOMY TUBE

Model Number 100/897/080CZ

Device Problem Gel Leak (1267)

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

Event Date 02/24/2021

Event Type  Injury  

Event Description

((b)(4)) ruptured cuff on posterior aspect.From mhra report: audible leak heard by staff nurse referred to ent following discussion with consultant ? cuff issue.No harm to patient.Scheduled tube change in theatre by ent surgeons.

Manufacturer Narrative

Other, other text: investigation of this customer complaint was limited because no sample was returned.Customer is claiming ruptured cuff which was discovered after placement/during use (based on incident report which is attached to related cc object in agile).During manufacturing process the devices are 100% inflation tested, which includes inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.Each cuff shall be also tested by customer prior use as per instruction for use as10001025-002 rev.100, point 9.2: "check the tracheostomy tube cuff (cuffed tube only) by test inflation." due to fact that cuff leak was observed after placement it is the most probable that reported failure occurred during tracheostomy procedure due to contact with sharp edge which is in conflict with instruction for use as10001025-002 rev.100, point 6.3: "guard against cuff damage by avoiding contact with sharp edges".Unfortunately without the sample we are unable to determine true root cause of this issue.No trend of confirmed complaints in relation with this issue was identified.

Event Description

No product was returned.Sme signed off with summary.

• Brand Name: PORTEX
• Type of Device: TRACHEOSTOMY TUBE
• MDR Report Key: 11675629
• MDR Text Key: 245755485
• Report Number: 3012307300-2021-03189
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315107207
• UDI-Public: 15019315107207
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 100/897/080CZ
• Device Catalogue Number: 100/897/080CZ
• Device Lot Number: 3900085
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 04/07/2021
• Supplement Dates FDA Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1