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

Model Number	750160
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-use check, the cuff was found stuck to the tube, which did not allow the cuff to be inflated.No patient injury.No additional information is available for this complaint.
Additional Manufacturer Narrative
Device evaluation a sample and picture were received to perform an investigation.A visual inspection of the picture detected no damage.Functional testing was performed by inflating the cuff.The cuff was inflated with 15cc of air and it inflated completely and symmetrically around the tube.The complaint was not confirmed.No root cause could be determinate since the sample successfully passed the functional test.A device history record (dhr) review was performed, and no issues were noted during manufacture.

• Brand Name: BIVONA MID-RANGE AIRE-CUF ADULT TRACHEOSTOMY TUB
• Common Device Name: TRACHEOSTOMY TUBE 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; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 13559573
• Report Number: 3012307300-2022-03639
• Device Sequence Number: 19947556
• Product Code: JOH
• UDI-Device Identifier: 15021312006407
• UDI-Public: 15021312006407
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2022

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: 06/04/2025
• Device Model Number: 750160
• Device Catalogue Number: 750160
• Device Lot Number: 3988245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2020
• 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