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

Device Problem Optical Discoloration (2999)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the pilot balloon component of the tracheostomy turned a blue color when water was used to inflate the cuff.The issue reversed once the water was removed.No patient injury was reported.

Manufacturer Narrative

Two (2) samples were received in used conditions, without their certificate of decontamination and without their original packaging inside a ziploc bag.Visual inspection was performed at 12? under normal lighting to received unit, in order to detect any damage on the cuff or airline.It was observed that the units have a blue condition on the pilot balloon, connector and tube.The complaint is confirmed.Functional test was performed where samples were filled with water to see if they turn blue.The samples did not turn blue after filling with water.They remained in the blue condition as received.By other side, after the water was removed from cuff, the water was clean.It is concluded that blue condition reported by the customer is a blue foreign substance since it is not adhered to samples material.Therefore, based on visual inspection and reviewing of manufacturing process where no sources of blue contamination were found, the most probable root cause is that damaged occurred after product left shm facilities.No corrective actions were taken.No lot number was provided; therefore, device history record (dhr) review could not be completed.Catalog number, lot number, unique identifier (udi) are unknown.No product information has been provided to date.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# 617147.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15459353
• MDR Text Key: 306194121
• Report Number: 3012307300-2022-19879
• 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: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1