MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC PORTEX TUBE SECUREMENT ENDOTRACHEAL; SUPPORT, BREATHING TUBE

Catalog Number	100/503/200
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the holder detached such that there was a risk of the tracheostomy tube being removed.No patient injury or complications were reported in relation to this event.

• Brand Name: PORTEX TUBE SECUREMENT ENDOTRACHEAL
• Common Device Name: SUPPORT, BREATHING TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8876323
• Report Number: 3012307300-2019-03828
• Device Sequence Number: 2447689
• Product Code: JAY
• UDI-Device Identifier: 15019315031823
• UDI-Public: 15019315031823
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: 35752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 08/08/2019

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: 04/23/2004
• Device Catalogue Number: 100/503/200
• Device Lot Number: 022825
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1