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

Catalog Number	67PFSS40
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/12/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical bivona flextend tts pediatric straight neck flange tracheostomy tube was noted to be leaking.The patient's mom was put 3.5 ml of water in the cuff and heard a leak.When she checked again, there was 2.4 ml of water in the cuff.No adverse patient effects were reported.
Additional Manufacturer Narrative
Lot numbers: 4101, 4103 codes were chosen as the lot number(s) of the samples were not reported.Device evaluation: two bivona devices were returned for investigation in used condition without their original packaging for evaluation.The sample was visually inspected and no discrepancies were found.A leak test was performed and when inflating the first unit with air, it was seen that the cuff inflated, but a part was not uniformly.The cuff was then 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.The second sample passed the inflation/leak test with no issues.Both samples also passed leak tests after being submerged under water and the airway line was manipulated.The assembly process was also reviewed using thirty two (32) units finding no discrepancies.A review of the manufacturing process was conducted and was considered adequate and correct.Based on the evidence and testing, the complaint was not confirmed.No fault was found with either of the returned samples.

• 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 55442
• MDR Report Key: 8904575
• Report Number: 3012307300-2019-03844
• Device Sequence Number: 2716289
• Product Code: JOH
• UDI-Device Identifier: 10351688518729
• UDI-Public: 10351688518729
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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: No Information
• Device Catalogue Number: 67PFSS40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 09/05/2019
• Initial Report FDA Received Date: 08/18/2019
• Supplement Report FDA Received Date: 10/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR