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

Model Number	ZZ19CN80NSC155N
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Skin Inflammation/ Irritation (4545)
Date of Event	01/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One tracheostomy tube was received for evaluation in relation to the reported event.Visual inspection was not able to detect any visual defect.Functional testing of the device was able to confirm and replicate the reported event.Leak testing found a cut in the cuff of the device.Root cause was unable to be determined due to the nature of the reported event.A dhr review was unable to be performed since no lot number was provided.
Event or Problem Description
It was reported that the tracheostomy tube had a leaking cuff.A hole was noticed in the cuff.Leaking of fluid from cuff necessitated aspiration to remove irritation by the cuff fluid.There was no patient injury reported.
Event or Problem Description
A customer response was attached to the complaint: the patient has a tetraplegia so there was no coughing reaction when water from the cuff ran into the lungs.As a result, the so2 fell sharply.The measures from the nurse was a deep, long suction process over minutes.
Additional Manufacturer Narrative
The adverse event required intervention which constitutes a serious injury.

• Brand Name: BIVONA 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: 13714868
• Report Number: 3012307300-2022-04427
• Device Sequence Number: 6363182
• Product Code: JOH
• UDI-Device Identifier: 15019517186932
• UDI-Public: 15019517186932
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ZZ19CN80NSC155N
• Device Catalogue Number: ZZ19CN80NSC155N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2022
• 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: 02/09/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown