MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL AIRE-CUF TRACHY TUBE 8.0MM; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	750180
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that after 24 hours in use, the cuff of a smiths medical tracheostomy deflated.No patient injury occurred and no medical intervention was required.

• Brand Name: SMITHS MEDICAL AIRE-CUF TRACHY TUBE 8.0MM
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9204671
• Report Number: 3012307300-2019-05753
• Device Sequence Number: 11540067
• Product Code: JOH
• UDI-Device Identifier: 15021312006421
• UDI-Public: 15021312006421
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

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: 10/19/2022
• Device Catalogue Number: 750180
• Device Lot Number: 3523749
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1