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

Device Problem Inflation Problem (1310)

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

Event Type  malfunction  

Manufacturer Narrative

This remediation mdr was generated under protocol b10010116, as a result of warning letter cms#617147.No lot number was provided; therefore device history record review could not be completed.A product sample was received for evaluation.Visual inspection revealed the sample was in used conditions, without original packaging and with its certificate of safe handling.During functional testing, the sample was filled with 5cc of air and when the sample was inflated with air, the cuff only inflated one side.According to the ifu (instructions for use) the pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times and all the times the cuff inflated completely and symmetrically, based on analysis the complaint is not confirmed.Root cause could not be determined since the sample successfully passed functional test.No corrective actions were taken since the complaint was not confirmed.

Event Description

It was reported that the cuff will not inflate.Pilot line does but cuff does not.During pre-test.No patient injury was reported.

• Brand Name: BIVONA TUBES NEO/PED
• 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: 16340277
• MDR Text Key: 309255090
• Report Number: 3012307300-2023-01095
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1