MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS MEDICAL BIVONA TUBES NEO/PED HYPERFLEX; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	60HA35
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received that a smiths medical bivona hyperflex tracheostomy tube had a neck plate on upside down.As a result, the patient was not properly ventilated, and a new tracheostomy was inserted.
Additional Manufacturer Narrative
Device evaluation in progress.
Event or Problem Description
Information was received that a smiths medical bivona hyperflex tracheostomy tube had a neck plate on upside down.As a result, the patient was not properly ventilated, and a new tracheostomy was inserted.It was further reported that the user noticed unspecified problems with two additional bivona hyperflex tracheostomy tubes.These unspecified product issues were identified prior to patient use.
Additional Manufacturer Narrative
Returned device was received in good physical condition.During the evaluation of the device, it was found that the device could move freely and the locking mechanism worked just fine.There is speculation that the defect was correctly communicated or the correct device was returned.Additionally since the neck flange rotates around the shaft, repositioning the neck flange so the flanges are not upside down would have corrected the concern and typically not warranted a complaint.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: SMITHS MEDICAL BIVONA TUBES NEO/PED HYPERFLEX
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane n; minneapolis MN 55442
• MDR Report Key: 9371228
• Report Number: 3012307300-2019-06798
• Device Sequence Number: 14169635
• Product Code: JOH
• UDI-Device Identifier: 15021312013702
• UDI-Public: 15021312013702
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/07/2020

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?: No
• Operator of Device: No Information
• Device Model Number: 60HA35
• Device Catalogue Number: 60HA35
• Device Lot Number: 38001467
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 01/22/2020; 03/03/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 02/19/2020; 05/08/2020
• 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