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

Catalog Number	750180
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Pneumonia (2011)
Date of Event	09/01/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that the cuff to a smiths medical portex® bivona® aire-cuf® adult tracheostomy tube deflated 4-6 times while in use.Steady cuff pressure was not able to be maintained which is believed to have led to patient aspirating secretions.Subsequently, it was required to perform trach tube change out as the patient was diagnosed with aspiration pneumonia.There were no further reported adverse effects.
Additional Manufacturer Narrative
Evaluation results: one 8.0 mm portex bivona tracheostomy tube with an aire-cuff mid range was returned for cuff leaking.The product cuff was leak tested.The cuff was inflated and the device was submerged in water to inspect for leaks.The device was manipulated and the cuff held the air and no leaks were present.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: PORTEX® BIVONA® 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: 9141825
• Report Number: 3012307300-2019-05263
• Device Sequence Number: 14132493
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: 750180
• Device Lot Number: 3528615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention