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

Model Number	750170
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problems or issues were identified during this device history review.One sample was received in used condition, with its original packaging and certificate of safe handling.During functional testing, the pump was inflated with air to see if there was any problem to inflate the cuff.The cuff inflated completely and symmetric around the tube.The complaint is not confirmed.Root cause could not be determined.No corrective actions were taken since the complaint was not confirmed.
Event or Problem Description
It was reported that the cuff was not inflating during pre-test.No patient injury was reported.

• Brand Name: SILICONE - BIVONA TUBES ADULT AIRE-CUF
• Common Device Name: TUBE TRACHEOSTOMY 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: 16752326
• Report Number: 3012307300-2023-04200
• Device Sequence Number: 8576406
• Product Code: JOH
• UDI-Device Identifier: 15021312006414
• UDI-Public: 15021312006414
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2025
• Device Model Number: 750170
• Device Catalogue Number: 750170
• Device Lot Number: 3942402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown