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

Model Number	60PFSS35
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that bivona tracheostomy tube was rigid and scratching the patient's throat.The trach was removed and replaced as a result.No patient complications were reported in relation to this event.
Additional Manufacturer Narrative
, corrected data: reportable event for follow-up report one switched to serious injury.
Additional Manufacturer Narrative
Other, other text: one sample were received in used condition.There was an excess of silicon found on the tube surface.The complaint was confirmed.Based on pfmea this failure condition could be caused by incorrect application of silicon, work instruction not followed.All mitigations on placed were verified and it was confirmed has been executing according, therefore no corrective actions could be implemented, it will be continue monitoring this failure condition in this product for threshold or escalation.As a preventive action production personnel was notified by quality engineer on 19/apr/2021 as awareness of the defect reported by the customer.

• Brand Name: BIVONA
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11439586
• Report Number: 3012307300-2021-01805
• Device Sequence Number: 3523481
• Product Code: JOH
• UDI-Device Identifier: 15021312516777
• UDI-Public: 15021312516777
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/24/2021

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: No Information
• Device Model Number: 60PFSS35
• Device Catalogue Number: 60PFSS35
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/08/2021
• Supplement Date Received by Manufacturer: 05/24/2021; 05/24/2021
• Initial Report FDA Received Date: 03/08/2021
• Supplement Report FDA Received Date: 05/24/2021; 05/24/2021
• 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 Age: 5 YR
• Patient Weight: 18