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

Catalog Number	67PFSS30
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that immediately on use of this tracheostomy tube, the cuff began leaking.A back up device was used to replace.No adverse patient effects were reported.
Additional Manufacturer Narrative
One tracheostomy tube was returned for evaluation.Device underwent functional testing to detect for leaks.Unit was inflated and subsequently submerged under water and observed for ten seconds.It was noted to be well inflated with no leakage occurring.Additionally, the balloon was squeezed and the airway line was moved back and forth; no leakage was detected.The reported customer complaint was unable to be confirmed.This investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.

• Brand Name: PORTEX BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7598362
• Report Number: 3012307300-2018-02268
• Device Sequence Number: 2193934
• Product Code: JOH
• UDI-Device Identifier: 10351688518675
• UDI-Public: 10351688518675
• 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): 09/10/2019

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: No Information
• Device Expiration Date: 09/08/2022
• Device Catalogue Number: 67PFSS30
• Device Lot Number: 3502334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1