MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® BIVONA® MID-RANGE AIRE-CUF® ADULT TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	750170
Medical Device Problem Codes	Fitting Problem (2183); Defective Component (2292); Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
Information was received indicating that the speaking valve was unable to connect to a smiths medical portex® bivona® aire-cuf® tracheostomy tube.It was noted that the 15mm connector is out of specification.There were no reported adverse effects.
Additional Manufacturer Narrative
One 7.0mm id portex bivona aire tracheostomy tube was returned for analysis.Upon visual examination an oval deformation was noted at the connector openings; confirming complaint.The connector on the returned device was inspected and determined not to match the manufacturing specification for od and taper.A 100% iso taper inspection was implemented immediately prior to packaging the product in january 2016.No internal failures were identified since implementing the 100% iso taper inspection.Based on the evidence, the root cause is unknown.

• Brand Name: PORTEX® BIVONA® MID-RANGE AIRE-CUF® ADULT TRACHEOSTOMY TUBE
• 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: 7805216
• Report Number: 3012307300-2018-03322
• Device Sequence Number: 1468990
• Product Code: JOH
• UDI-Device Identifier: 15021312006414
• UDI-Public: 15021312006414
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,user facilit
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2018

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: Lay User/Patient
• Device Expiration Date: 08/28/2020
• Device Catalogue Number: 750170
• Device Lot Number: 3043467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 08/22/2018
• Supplement Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1