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

Catalog Number	XT16JS65NSC006S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that the left eyelet to a smiths medical portex bivona flextend¿ tts¿ tracheostomy tube was observed to break during routing trach site care.It was reported that the reported to be "sticky and gummy following 5 sterilization cycles.The tube was reported to be used a total of six times and sterilized five times for the past year.Subsequently, the trach tube was immediately changed out with no further adverse effects.
Event or Problem Description
Information was received that incident occurred during routine trach care, which includes cleaning of the tracheostomy site.A tracheostomy tube change out occurred immediately.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿ 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: 8879800
• Report Number: 3012307300-2019-04029
• Device Sequence Number: 216280
• Product Code: JOH
• UDI-Device Identifier: 15019517075915
• UDI-Public: 15019517075915
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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: 11/30/2022
• Device Catalogue Number: XT16JS65NSC006S
• Device Lot Number: DS011054
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 08/09/2019
• Supplement Report FDA Received Date: 09/13/2019
• 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: Required Intervention