MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOMIZED TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	CMZ1925N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the trach tube's balloon would not inflate.Additional information received via return call on (b)(6) 2022: issue was discovered during pre-test.No patient involvement or adverse affects.
Additional Manufacturer Narrative
The complaint sample was returned for evaluation.Visual inspection device by the unaided eye did not reveal any defects.Using a syringe, 5ml of air was inserted through the valve.The cuff partially inflated.The instruction for use, states under set up and use to attach a syringe to the pilot balloon and slowly test inflate the cuff with 5ml of sterile water for pediatrics cuffs and 10ml of sterile water for adult cuffs.If the cuff does not inflate completely, squeeze the pilot balloon while gently manipulating the cuff from the shaft.Following the ifu, the cuff inflated.The reported problem was not confirmed.No corrective actions are planned at this time.There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15117200
• Report Number: 3012307300-2022-14378
• Device Sequence Number: 20451555
• Product Code: JOH
• UDI-Device Identifier: 15019517113631
• UDI-Public: 15019517113631
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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 Model Number: CMZ1925N
• Device Catalogue Number: CMZ1925N
• Device Lot Number: GA029635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• 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: 06/30/2022
• Supplement Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• 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