MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA AIR-CUF NEONATAL V NECK FLANGE TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF PRODUCT CODE: JOH

Catalog Number	65N040
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: foreign: (b)(6).
Event or Problem Description
Information was received that during the use of a smiths medical bivona air-cuf neonatal v neck flange tracheostomy tube, the cuff was inflated and the indicator needle rose to 30cm h2o and dropped to 0cm h2o and failed to maintain pressure.The valve of the cuff was removed.The parameters of the ventilator were checked and no parameters indicated leakage.This was noticed after four days of installation.No adverse effects were reported.
Additional Manufacturer Narrative
Two photographs were returned for evaluation.Visual inspection found the pilot balloon to be detached from the unit.No functional testing was conducted as no product was received.32 assemblies were reviewed of the complete manufacturing process of air way and balloon.Production personnel perform a visual inspection to detect any damage on the inflation lines on 100 percent of the product.The units are then inflated with air and visually inspected to see that the cuff inflated uniformly.A leak test is performed as well on each.The reported customer complaint has been confirmed; the most probable cause of issue has been determined to be that damage occurred after the product left the shm facility.

• Brand Name: BIVONA AIR-CUF NEONATAL V 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 55442
• MDR Report Key: 8698574
• Report Number: 3012307300-2019-03615
• Device Sequence Number: 11380841
• Product Code: JOH
• UDI-Device Identifier: 15021312005936
• UDI-Public: 15021312005936
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K944178
• 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): 10/04/2019

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: 06/26/2023
• Device Catalogue Number: 65N040
• Device Lot Number: 3659603
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 06/14/2019
• Supplement Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 MO