MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67SP055
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pre-test of a routine trach change, two cuffs inflated asymmetrically.A third trach was used to completed the trach change.No patient injury was reported.
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Two product samples were received for evaluation.Visual and functional testing were performed.Visual inspection was performed at 12" under normal lighting to received unit, in order to detect any damage on the cuff, airline or pilot balloon.Water was observed inside the units.Sample was filled with 5cc of air when inflating sample 1 with air, the cuff inflated without problems and when inflating the sample 2, the cuff only inflated one side.According to the instruction for use( ifu) the cuff was manipulated and the whole cuff inflated.However, extremely force was required to inflate the cuff.(teflon was not properly distributed inside the cuff).The reported issue was confirmed.A corrective and preventative action has been opened to determine the root cause and implement proper corrective actions.This mdr was generated under protocol b10009704.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY
• 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): 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: 15277446
• Report Number: 3012307300-2022-15896
• Device Sequence Number: 17881558
• Product Code: JOH
• UDI-Device Identifier: 15021312000757
• UDI-Public: 15021312000757
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2023
• Device Model Number: 67SP055
• Device Catalogue Number: 67SP055
• Device Lot Number: 3715028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2018
• 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