MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BIVONA FLEXTEND 5.0 TTS NS CUSTOM; TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH

Model Number	FT19EN60NGC076N
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that the cuff on a smiths medical portex bivona flextend 5.0 tts ns custom trach tube the eyelet ripped after 6 months of use.No adverse effects were reported.
Event or Problem Description
Investigation completed on a smiths medical tracheostomy|silicone - bivona tubes custom.Summary in h -10.
Additional Manufacturer Narrative
Investigation results completed on a smiths medical flextend tracheostomy tube 6.0 the complaint of eyelets flange torn was visually inspected torn completely through.The second was partially torn but still intact.The end partially torn passed instrom machine testing at 11.2 lbf requirement.Pictures provided in attachments.Dhr revealed no discrepancies with lot (3863189) prior to use.Theory of tube holder may have sharp edges and contact with eyelets causing damage.Warning on package.Recommendation to use tape twill as decannulation may have caused compromised in airway control.

• Brand Name: PORTEX BIVONA FLEXTEND 5.0 TTS NS CUSTOM
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 10064164
• Report Number: 3012307300-2020-04168
• Device Sequence Number: 3752940
• Product Code: JOH
• UDI-Device Identifier: 15019517192070
• UDI-Public: 15019517192070
• Combination Product (Y/N): N
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2020

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: 09/11/2024
• Device Model Number: FT19EN60NGC076N
• Device Catalogue Number: FT19EN60NGC076N
• Device Lot Number: DS032092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 05/17/2020
• Supplement Report FDA Received Date: 06/16/2020
• 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
• Patient Age: 15 YR
• Patient Weight: 29