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

Model Number	FT20EN65NSD031N
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/13/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating that the obturator to a smiths medical portex bivona custom tracheostomy tube was reported to be catching when attempting to place.There were no reported adverse patient effects.
Additional Manufacturer Narrative
Additional information was received indicating that the trach tube was not placed in the patient.There were no reported adverse effects.One portex bivona custom trach tube was returned for analysis with no defects.The device is noted to have an adult curve with straight 1a length of 30mm.The obturator curve closely resembles the shape of the device and will drag along the inside of the shaft.The obturator is designed so that shape can be changed by the caregiver to facilitate insertion and removal for the individual end user.Bending the obturator so that it is more in a u shape may work for easier insertion and removal.This could not be confirmed during the investigation.Adding a water-soluble lubricant to the tip of the obturator will reduce the drag and allow easier removal of the obturator; confirmed during the investigation.Based on the evidence, the complaint is confirmed.The root cause was found due to design.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10150439
• Report Number: 3012307300-2020-05856
• Device Sequence Number: 11342514
• Product Code: JOH
• UDI-Device Identifier: 15019517228212
• UDI-Public: 15019517228212
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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: FT20EN65NSD031N
• Device Catalogue Number: FT20EN65NSD031N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/13/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 36