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

Device Problem Inflation Problem (1310)

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

Event Type  malfunction  

Event Description

It was reported that the first trach was tested and the pilot balloon inflated but the cuff did not.No patient injury was reported.

Manufacturer Narrative

Udi: unknown.No product information has been provided to date.This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.A device history record (dhr) review was conducted which indicated all inspections were completed for the potential lots and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.Two (2) samples were received from in used conditions, without their original packaging and with their certificate of decontamination.Air cuff symmetry test was performed to the unit according to procedures.When the sample 1 was inflated with air, cuff only inflated one side.When the sample 2 was inflated, the pilot balloon inflated but all the air was stuck it.According to the information for use, the cuff was manipulated, and it was inflated completely.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely.When the cuffs were measured, the percentage for the symmetry was for sample 1:45 and sample 2:47.These results are over 33.3 that is the minimum acceptable.Based on the test, the units are within specification the root cause of the reported issue could not be confirmed since the samples successfully passed cuff symmetry test.No corrective actions were taken since the complaint was not confirmed.

• 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: 16174577
• MDR Text Key: 308531012
• Report Number: 3012307300-2023-00512
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2023
• 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: 03/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/03/2023
• 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