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

Model Number	505080
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|pvc - portex tubes dic malfunctioned.Reported that patient went to the or for tracheostomy.On unit after returned, it was noticed patient had a continuous cuff leak.Respiratory therapist states air was put into the cuff and deflated not long after on own.Trauma and md notified.Trach removed and patient was re-intubated.Patient had to return to or.On inspection of trach (held under water), seemed to leak on top between cuff and tube.
Additional Manufacturer Narrative
Investigation completed on a smiths medical tracheostomy|pvc - portex tubes dic was tested under water leak test, which revealed bubbles when submerging under water.Then upon further investigation a tear was found in the material of cuff.The complaint was verified.Reviewing manufacturing testing the report indicated passing at 100% prior to release.Unknown cause of event and will continue to monitor for future issues.
Event or Problem Description
Device evaluation completed and summary.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11519084
• Report Number: 3012307300-2021-02248
• Device Sequence Number: 4087928
• Product Code: BTR
• UDI-Device Identifier: 10351688021007
• UDI-Public: 10351688021007
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K934465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2021

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?: Yes
• Operator of Device: No Information
• Device Model Number: 505080
• Device Catalogue Number: 505080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention