MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. AIRE-CUF TRACHY TUBE 7.0MM ADLT MID-RNGE,ADJUST HYPERFLEX; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	75HA70
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported that during a pre-test check, the cuff component of the tracheostomy tube failed to inflate equally.No death or serious injury was reported in connection with this incident.
Additional Manufacturer Narrative
One mid-range adjustable hyperflex tracheostomy (trach) was returned for analysis in good condition.Inflation test was performed by using a syringe to inflate the cuff with 20cc of air.The cuff symmetry did not exceed the 1/3:2/3 for an aire cuff trach.The cuff was removed from the shaft and four thickness measurements of the cuff were taken using a digital mitutoyo thickness gage; all measurements are within specification.Based on the evidence, the root cause is unknown as the complaint could not be confirmed.

• Brand Name: AIRE-CUF TRACHY TUBE 7.0MM ADLT MID-RNGE,ADJUST HYPERFLEX
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7861774
• Report Number: 3012307300-2018-03585
• Device Sequence Number: 1565546
• Product Code: JOH
• UDI-Device Identifier: 15021312013849
• UDI-Public: 15021312013849
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2018

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 Catalogue Number: 75HA70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 09/10/2018
• Supplement Report FDA Received Date: 10/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1