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

Catalog Number	60SP055
Medical Device Problem Code	Split (2537)
Health Effect - Clinical Codes	Respiratory Distress (2045); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: (b)(6).
Event or Problem Description
Information was received indicating that splits were noted to a smiths medical bivona® uncuffed tracheostomy tube.Subsequently, the patient underwent a tracheostomy (trach) change out and recovered following.No adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was received indicating that an emergency tracheostomy (trach) change out was performed due to the increase in secretions.The splits were noted at the base of the tube upon removing the trach.No further information was provided.
Additional Manufacturer Narrative
One smiths medical bivona® uncuffed tracheostomy tube was returned for analysis in used condition.Upon visual inspection is was noted that the sample had splits in the shaft with an exposed wire inside.Relevant document were reviewed and deemed adequate.A review of the manufacturing process was completed and found adequate.The assembly process was performed according to the procedures along with confirming training records.Thirty two assemblies were reviewed to see if they had a molding issue.The instructive "(b)(4), pedi-neo uncuffed ifu was reviewed.On section 5.8 states: "during reprocessing, aggressive scrubbing of the tube or use hard bristled brushes or sharp wire mounted swabs may damage the surface of the tube." it was seen that: receiving inspection verifies: part workmanship and appearance of a representative sample for each lot according to the quantity received.Production personnel inspects the parts 100% before assembling them to see if they have any molding issue such as voids/splits.Additional they inspect 100 % once cured to see if they have any molding issue such as exposed wire, voids/splits.Quality takes a representative sample and performs a visual inspection for exposed wire according to qp bivona (b)(4) - inspection for bivona finish goods.Based on the evidence, the complaint was confirmed with the root cause being due to manufacturing.

• Brand Name: PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES
• 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: 7275067
• Report Number: 3012307300-2018-00275
• Device Sequence Number: 123500
• Product Code: JOH
• UDI-Device Identifier: 15021312000436
• UDI-Public: 15021312000436
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2018

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: No Information
• Device Expiration Date: 03/03/2022
• Device Catalogue Number: 60SP055
• Device Lot Number: 3368075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Supplement Date Received by Manufacturer: 02/21/2018; 06/07/2018
• Initial Report FDA Received Date: 02/15/2018
• Supplement Report FDA Received Date: 02/26/2018; 07/03/2018
• 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