MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA UNCUFFED TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	60P040
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical bivona uncuffed tracheostomy tube coil broke while in use with a patient.Subsequently, a tracheostomy (trach) tube change out was required and the broken trach was replaced with a non-smiths medical trach tube.The patient was also on a ventilator and was reported to be in stable condition.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Device evaluation: a smiths medical bivona uncuffed tracheostomy tube was received without its original packaging.Visual inspection was performed, and it was seen that the shaft was separated from the connector and the wire was stretched, it was observed that the whole adhesive was attached to the connector.In addition contamination was found inside the tube and on the shaft during the visual inspection.A review of the manufacturing process for p/n 60pfs40 and l/n 3794389, was conducted by quality engineer on 30/apr/2019.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 splits/cuts, exposed wire according to qp bivona tt-fg-tj rev.109 - inspection for bivona finish goods.The most probable cause for the reported condition is that the damaged occurred after the product left the manufuacturing facility.

• Brand Name: BIVONA UNCUFFED TRACHEOSTOMY TUBE
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8053130
• Report Number: 3012307300-2018-08128
• Device Sequence Number: 11159442
• Product Code: BTO
• UDI-Device Identifier: 15021312005752
• UDI-Public: 15021312005752
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2019

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 Catalogue Number: 60P040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 05/25/2019
• 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
• Patient Age: 17 MO
• Patient Weight: 10