MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA AIRE-CUF NEONATAL TRACHEOSTOMY TUBES; TRACHEOSTOMY TUBE AND TUBE CUFF

Catalog Number 65N040

Device Problem Leak/Splash (1354)

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

Event Date 02/01/2022

Event Type  malfunction  

Event Description

It was reported that two weeks after the customer started to use the product, leakage of air from the cuff was observed.No patient injury.No additional information is available.

Manufacturer Narrative

D4 udi and g5 are unknown.No product information has been provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.One picture was included in agile attachments section for evaluation.One sample was received in used conditions, without original packaging and with its certificate of safe handling.Sample was filled with 5 cubic centimeters (cc) of air according to procedure to see if there was any functional problem.When the sample was inflated with air, the cuff only inflated one side.According to the information for use (ifu)the pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the time the cuff inflated completely and symmetrically, based on analysis the complaint was not confirmed.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.No actions were taken.

• Brand Name: BIVONA AIRE-CUF NEONATAL TRACHEOSTOMY TUBES
• Type of Device: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 14017342
• MDR Text Key: 288664259
• Report Number: 3012307300-2022-05878
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/03/2023

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 Catalogue Number: 65N040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 03/09/2022
• Supplement Dates FDA Received: 05/03/2023
• 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