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

Model Number	100/110/080
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a pre-use check, the customer suspected air was leaking from the cuff of a smiths medical trach tube.No patient injury.
Additional Manufacturer Narrative
Other, other text: two photos and one sample were returned for evaluation.No defects were observed during visual analysis.The returned sample was inflated using a syringe.Occlusion was detected at the solvent joint between the pilot balloon and inflation line; the complaint was confirmed.Based on the analysis conducted in the sample provided, cuff inflation/deflation failure mode was confirmed.Therefore, according to on pfmea (rmp 1045) the occurrence of this failure condition could be caused by: method not followed (excess solvent thf at joint).All mitigations on placed were verified and it was confirmed has been executing according, therefore no corrective actions could be implemented, it will be continue monitoring this failure condition in this product for threshold or escalation.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11646640
• Report Number: 3012307300-2021-03039
• Device Sequence Number: 2899787
• Product Code: BTR
• UDI-Device Identifier: 15019315050800
• UDI-Public: 15019315050800
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2021

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?: No
• Operator of Device: No Information
• Device Model Number: 100/110/080
• Device Catalogue Number: 100/110/080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 05/09/2021
• Initial Report FDA Received Date: 04/10/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1