MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	ST18FN45NTF164N
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that the balloon to a smiths medical portex® bivona® tts¿ tracheostomy tube was not inflated.It was reported that the patient's oxygen saturation was noted to be low while getting ready for bed.After calling the physician, the tracheostomy (trach) was then checked and balloon was not inflated.Subsequently, the tube was removed.The balloon was then inflated with water, left to sit, and the water was reported to have come out.There were no reported adverse patient effects.
Additional Manufacturer Narrative
One flextend tracheostomy tube with fixed connector, tts cuff and talk attachment was returned for analysis; not matching part number previously given by customer.The sample was leak tested by inflating the cuff with air and manipulating the components.A slow leak was observed and was noted to be coming from under the connector.The connector was removed and leak tested again.The source of the leak was observed at the lumen on the proximal end; noting insufficient adhesive backfilled.Magnification was then used to examine the sample to note the leak location.Based on the evidence the complaint was confirmed.The root cause was found due to insufficient adhesive at proximal end of lumen leading to a manufacturing issue.

• Brand Name: PORTEX® BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBES
• 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: 8052305
• Report Number: 3012307300-2018-08114
• Device Sequence Number: 1526799
• Product Code: JOH
• UDI-Device Identifier: 15019517156836
• UDI-Public: 15019517156836
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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?: No
• Operator of Device: No Information
• Device Expiration Date: 06/27/2023
• Device Catalogue Number: ST18FN45NTF164N
• Device Lot Number: DS017990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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: Life Threatening; Required Intervention