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

Model Number	60NFP35
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer facility phone number: (b)(6).Device evaluation in progress.
Event or Problem Description
It was reported that there was a tiny hole in the bottom of the flextend portion of the bivona tracheostomy tube.This was near the outer hub, and was exposing the viewing of the wire in the flextend portion.This product fault was noticed after a whistling sound was heard coming from the child.The ventilator, which was also on, was alarming.The patient's mother tried to suction the child's tube but she was unable to insert the suction catheter to the needed suction depth.The mother thought that there was a blockage.After suspecting this, the mother performed a tracheostomy tube change.No patient injury, or further complications were reported in relation to this event.
Additional Manufacturer Narrative
Other, other text: , corrected data: patient age corrected in section a.
Additional Manufacturer Narrative
Other, other text: one sample was returned and a tube was found to be crushed in the same place a cut in the silicon was found.Based on the conditions of sample received i.E.Used and crushed on surface tube.The most probable root cause is that the unit became damaged after left smiths medical facilities.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• 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: 11494541
• Report Number: 3012307300-2021-02097
• Device Sequence Number: 5349312
• Product Code: JOH
• UDI-Device Identifier: 15021312014730
• UDI-Public: 15021312014730
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2021

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: Lay User/Patient
• Device Expiration Date: 02/07/2023
• Device Model Number: 60NFP35
• Device Catalogue Number: 60NFP35
• Device Lot Number: 3585196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 03/16/2021; 04/26/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 03/17/2021; 06/01/2021
• 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: Life Threatening; Required Intervention
• Patient Age: 1 YR
• Patient Weight: 6