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

Catalog Number CON-ISO-035-0

Device Problem Contamination of Device Ingredient or Reagent (2901)

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

Event Type  malfunction  

Event Description

It was reported that the 3.5mm iso connector component of the bivona tracheostomy tube had embedded particulates.No death or serious injury was reported in connection with this incident.

Manufacturer Narrative

Other, other text: no product was returned for analysis.However, a photograph was obtained with the investigation to reference.Upon review of the photo, embedded particulates displayed on the 3 iso connectors within 0.40 mm maximum acceptance limit per incoming material specification.Based on the evidence, the complaint was confirmed by photograph review.However, the root cause is unknown., corrected data: g7, previously submitted 01-nov-2018.

• Brand Name: BIVONA® SILICONE TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd avenue,; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd avenue,; gary IN 46406
• Manufacturer Contact: dave halverson ; 1265 grey fox road; st. paul, MN 55112 ; 7633833310
• MDR Report Key: 7907266
• MDR Text Key: 121718676
• Report Number: 3012307300-2018-03768
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 06/20/2022
• Device Catalogue Number: CON-ISO-035-0
• Device Lot Number: 3442483
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1