MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number 67SP045

Device Problem Leak/Splash (1354)

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

Event Date 06/07/2021

Event Type  malfunction  

Event Description

It was reported that during pre-testing of a new device, it was found that it was not inflating fully despite manipulations.No patient injury was reported.

Manufacturer Narrative

One sample was received in used conditions without its original packaging.When the sample was inflated with air, the cuff only inflate one side.The pilot balloon was manipulated and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely.When measuring the cuff, the percentage for the symmetry 33.3 percent.This result is equal to 33.3 percent that is the minimum acceptable.Based on the test, the unit is within spec.The complaint is not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 15410647
• MDR Text Key: 306086950
• Report Number: 3012307300-2022-18934
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312000733
• UDI-Public: 15021312000733
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K914088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2024
• Device Model Number: 67SP045
• Device Catalogue Number: 67SP045
• Device Lot Number: 3775451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1