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

Model Number	100/897/080CZ
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the tracheostomy, the smiths medical cuff started to slowly deflate and a leak was noticed afterward.Clinical consequences were desaturation and hypoxemia.A tube change was carried out.No further adverse patient effects were reported.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• MDR Report Key: 10841497
• Report Number: 3012307300-2020-11461
• Device Sequence Number: 11519330
• Product Code: BTO
• UDI-Device Identifier: 15019315107207
• UDI-Public: 15019315107207
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 11/15/2020

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: Health Professional
• Device Expiration Date: 07/22/2020
• Device Model Number: 100/897/080CZ
• Device Catalogue Number: 100/897/080
• Device Lot Number: 3986066
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 11/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1