MAUDE Adverse Event Report: PORTEX; TRACHEOSTOMY TUBE

Model Number	100/897/080CZ
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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 or Problem Description
No product was returned.Sme signed off with summary.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY TUBE
• MDR Report Key: 11675629
• Report Number: 3012307300-2021-03189
• Device Sequence Number: 19558111
• Product Code: BTO
• UDI-Device Identifier: 15019315107207
• UDI-Public: 15019315107207
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Expiration Date: 12/10/2024
• 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 Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 05/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1