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

Model Number	67SP030
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
It was reported that the cuff component of the bivona tracheostomy tube failed to inflate.This product problem was observed during testing.There was no patient involvement.
Additional Manufacturer Narrative
Other, other text: additional information received on 11-nov-2020: balloon did not inflate on testing.Occurred prior to use with a patient, corrected data: file changed to non reportable.This could not go undetected as precheck list in critical care describes the issue discovered prior.
Additional Manufacturer Narrative
Other, other text: additional information: h6.D5 and e4 are unknown.No information has been provided to date.Device evaluation: one sample was returned for investigation.A visual inspection of the sample found no damage.During functional testing, the sample was filled with air in order to see if there was any functional problem.When the unit was inflated with air, the pilot balloon inflated but all air was stuck in it.After the whole cuff inflated, we deflated and inflated 4 times, all the times the cuff inflated completely.The reported failure was not confirmed.The root cause cannot be established.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147., corrected data: correction information: d1, h11 file changed from non-reportable to reportable event.
Additional Manufacturer Narrative
Other, other text: additional information: h6.D5 and e4 are unknown.No information has been provided to date.Device evaluation: one sample was returned for investigation.A visual inspection of the sample found no damage.During functional testing, the sample was filled with air in order to see if there was any functional problem.When the unit was inflated with air, the pilot balloon inflated but all air was stuck in it.After the whole cuff inflated, we deflated and inflated 4 times, all the times the cuff inflated completely.The reported failure was not confirmed.The root cause cannot be established.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).File changed from non-reportable to reportable event.

• Brand Name: BIVONA AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE
• 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; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10938275
• Report Number: 3012307300-2020-12043
• Device Sequence Number: 791003
• Product Code: JOH
• UDI-Device Identifier: 15021312000696
• UDI-Public: 15021312000696
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/31/2022

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
• Device Expiration Date: 01/14/2025
• Device Model Number: 67SP030
• Device Catalogue Number: 67SP030
• Device Lot Number: 3931152
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/19/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/06/2020; 07/09/2022; 07/09/2022
• Initial Report FDA Received Date: 12/03/2020
• Supplement Report FDA Received Date: 01/06/2021; 09/20/2022; 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown