MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH

Model Number	67PFS30
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign report source: (b)(6).
Event or Problem Description
Information was received that the cuff was not inflating on a smiths medical bivona flextend tts pediatric straight neck flange tracheostomy tube.A trach change was done to resolve the issue.No adverse patient effects were reported.
Additional Manufacturer Narrative
Investigation completed on a smith medical tracheostomy|silicone - bivona tubes neo/ped.Device received with l/n 3832010.The device was visually inspected with no damage noted.Testing done according to the ifu (10018859-001 rev.100 - instruction for use - bivona tts flextend tracheostomy) the cuff was manipulated and the whole cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely.Pictures provided.As preventive action production personnel was notified by quality engineer on (b)(6) 2020 as awareness of the defect reported by the customer.The complaint could not be verified or validated.No fault found with device.
Event or Problem Description
Investigation completed on a smiths medical investigation completed on a smith medical tracheostomy|silicone - bivona tubes neo/ped.Summary in h-10.

• Brand Name: BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE
• 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: 10012629
• Report Number: 3012307300-2020-03346
• Device Sequence Number: 14223555
• Product Code: JOH
• UDI-Device Identifier: 10351688518606
• UDI-Public: 10351688518606
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: 67PFS30
• Device Catalogue Number: 67PFSS30
• Device Lot Number: 3832010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 04/30/2020
• Supplement Report FDA Received Date: 07/10/2020
• 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: 1 YR