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

Catalog Number 60P040

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/09/2018

Event Type  malfunction  

Event 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.

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
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8053130
• MDR Text Key: 126598238
• Report Number: 3012307300-2018-08128
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15021312005752
• UDI-Public: 15021312005752
• Combination Product (y/n): N
• PMA/PMN Number: K912469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: No Information
• Device Catalogue Number: 60P040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 05/02/2019
• Supplement Dates FDA Received: 05/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 17 MO
• Patient Weight: 10