MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. PORTEX® BIVONA® TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67P035
Medical Device Problem Codes	Material Discolored (1170); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown as to which trach tube had inflation issues and as to which tubes had discoloration issues.
Event or Problem Description
Information was received indicating that during a routine change out of a smiths medical portex® bivona® tts¿ (tight-to-shaft) tracheostomy tube discoloration of the flange was observed.It was reported by the nurse that discoloration (light yellow - orange) on inner aspect of the flanges was noted.Two trach tubes were noted at bedside; one with same discoloration and one without.The patient had been reported to be undergoing proton therapy in mri.Subsequently, the replacement tube was reported to not inflate properly with sterile water during pre-test; only 2/3 around the shaft inflated.Massaging of the cuff was performed without success.A tube was finally placed with no adverse patient effects.
Additional Manufacturer Narrative
Evaluation results: two used tracheostomy tubes (67p035 l/n 3494019) were received for investigation without their original packaging inside a ziploc bag.The samples were received in used condition and with their respective certificates of decontamination.Visual inspection was performed at 12 inches under normal lighting on the received units to look for any damage on the cuffs.During the visual inspection, the investigator found contamination/discoloration on one of the neckstraps.Following this visual examination, the units were inflated with 5 cc of air in order to see if there were any problems with inflating the cuffs.The cuffs inflated in a manner that was not uniform.The cuffs were then manipulated according the instructions for use (ifu), and they inflated uniformly.The cuff s were then inflated and deflated four more times.The cuffs inflated properly during each trial.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.With respect to the discoloration that was observed the investigator identified the following most probable root cause.The damaged or discoloration occurred after the product left the manufacturing facility.With respect to the cuff asymmetry, the complaint was not confirmed.The cuffs were inflating as intended after the ifus were followed.

• Brand Name: PORTEX® BIVONA® TTS¿ (TIGHT-TO-SHAFT) 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: 9077775
• Report Number: 3012307300-2019-05010
• Device Sequence Number: 19577382
• Product Code: JOH
• UDI-Device Identifier: 15021312006261
• UDI-Public: 15021312006261
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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 Expiration Date: 08/31/2022
• Device Catalogue Number: 67P035
• Device Lot Number: 3494019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 10/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 YR