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

Catalog Number	67P045
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the cuff of a portex® bivona® pediatric tts¿ tracheostomy tube didn't remain inflated.The deflation occurred after 20 days in use.The tracheostomy tube was changed nine days early, immediately after noticing the cuff was deflated.The patient was monitored by nurses because of a "risk for inhalation".No injury was reported.
Additional Manufacturer Narrative
Smiths medical received one portex® bivona® pediatric tts¿ tracheostomy tube with obturator.Visual inspection revealed that the cuff was damaged due to over-inflation.The instructions for use was reviewed and states to attach a syringe to the pilot balloon and slowly inflate the cuff with 5ml of sterile water and if the cuff does not inflate completely, squeeze the pilot balloon while gently manipulating the cuff from the shaft.Manufacturing process reveals that this product was 100% leak tested and would have failed inspection.Based on the evidence, the root cause is from over-inflation of the cuff.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.The investigation did not determine a manufacturing defect.

• Brand Name: PORTEX® BIVONA® PEDIATRIC TTS¿ 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: 6862323
• Report Number: 3012307300-2017-02046
• Device Sequence Number: 10981234
• Product Code: JOH
• UDI-Device Identifier: 15021312006285
• UDI-Public: 15021312006285
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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: Nurse
• Device Expiration Date: 04/18/2021
• Device Catalogue Number: 67P045
• Device Lot Number: 3190399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 09/13/2017
• Supplement Report FDA Received Date: 01/09/2018
• 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