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

Model Number	755190
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Device lot number is unknown, no product information has been provided to date.
Event or Problem Description
It was reported that the cuff of the cannula is deformed.Patient has irritated skin.Additional information was received stating the lot number is unknown.
Additional Manufacturer Narrative
Other, other text: h6: event problem and evaluation codes: updated.H3: device evaluated by manufacturer: updated.Visual inspection of the returned device by the unaided eye revealed a crease on the cuff.No other anomalies were identified.Using a syringe, 20 milliliters of air was inserted through the valve.The cuff fully inflated with a slight bulge.The cuff was measured with a standard ruler from the center of the shaft to the edge of the smaller side of the cuff.Next, the cuff was measured from the center of the shaft to the edge of the larger side of the cuff.The measurements were 14millimeters and 20millimeters.The measurements met the manufacturing specification for cuffs.The alleged defects could not be confirmed.No corrective actions are planned currently.The manufacturer regularly analyzes complaint data and trends and will take further actions accordingly.No lot number was provided; therefore, device history record review could not be completed.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4)., corrected data: correction: no lot/serial number was provided, therefore the product manufacture or expiration date was unknown.

• Brand Name: BIVONA 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: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15414246
• Report Number: 3012307300-2022-19002
• Device Sequence Number: 5653148
• Product Code: JOH
• UDI-Device Identifier: 15021312006490
• UDI-Public: 15021312006490
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2023

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: 755190
• Device Catalogue Number: 755190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 05/11/2023
• 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
• Patient Sex: Unknown