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

Model Number 60PFSS35

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem Unspecified Tissue Injury (4559)

Event Type  Injury  

Event 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.

Manufacturer Narrative

, corrected data: reportable event for follow-up report one switched to serious injury.

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
• Type of Device: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 11439586
• MDR Text Key: 238566587
• Report Number: 3012307300-2021-01805
• Device Sequence Number: 1
• Product Code: JOH
• UDI-Device Identifier: 15021312516777
• UDI-Public: 15021312516777
• Combination Product (y/n): N
• PMA/PMN Number: K944178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 5 YR
• Patient Weight: 18