MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. PORTEX® PER-FIT¿ TRACHEOSTOMY TUBE AND KITS; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	536080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The tracheostomy tube is for single patient use, but can be used multiple times on the same patient.One portex® per-fit¿ tracheostomy tube was received for analysis.Visual check of the cuff with unaided eye revealed no issue.The cuff was inflated with air and exhibited a slow deflation.The device was submerged underwater and air bubbles were observed.Further evaluation of the suspected area under magnification observed a small opening, located on the side of the cuff.The physical characteristics of the edges of the compromised area is consistent with breakage.A review of the manufacturing and quality inspection processes were reviewed and considered adequate and correct.The failure mode of cuff breakage was confirmed.The root cause is unknown.
Event or Problem Description
It was reported that the cuff of a portex® per-fit¿ tracheostomy tube would not retain air.The cuff was tested by the doctor prior to insertion; but once inserted, the balloon on the cuff would not hold air.There was no patient injury associated with this occurrence.

• Brand Name: PORTEX® PER-FIT¿ TRACHEOSTOMY TUBE AND KITS
• 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: 7317136
• Report Number: 3012307300-2018-00461
• Device Sequence Number: 11118822
• Product Code: JOH
• UDI-Device Identifier: 10351688051943
• UDI-Public: 10351688051943
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K031057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/25/2022
• Device Catalogue Number: 536080
• Device Lot Number: 3503950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention