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

Model Number	HU20IS55NSF064N
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	01/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an unplanned trache change due to respiratory distress and reduced oxygen saturations.The customer felt it to be a blocked tube.When the parent initially inserted this tube, all was well but when the parent attempted to pass suction catheter down trache they were unable to advance the catheter.The trache tapes released and able to pass suction catheter easily, but unable to pass suction catheter when secured at normal tension.As a temporary measure, the trache was secured at a much looser tension.A new tube from a different batch number was used to resolve the issue.
Additional Manufacturer Narrative
Other text: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Two (2) product samples were received for evaluation.Visual and functional testing were performed.Visual inspection did not reveal any anomalies.Functional testing found there was no resistance when the device was in its free state, little to no resistance in passing a 12 fr catheter when the device was bent to represent a 120 to 90 degree curve.Bending the shaft more acutely did cause resistance with passing the suction catheter.It is likely the positioning of the patient caused internal pressures on the tube to be bent in a manner that did not allow easy suctioning.The reported problem could not be confirmed.Root cause cannot be determined as the samples were successfully tested and no discrepancies were detected.

• Brand Name: BIVONA CUSTOMIZATION
• Common Device Name: TRACHEOSTOMY TUBE AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13552839
• Report Number: 3012307300-2022-03600
• Device Sequence Number: 20098705
• Product Code: JOH
• UDI-Device Identifier: 15019517242362
• UDI-Public: 15019517242362
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2022

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 Model Number: HU20IS55NSF064N
• Device Catalogue Number: HU20IS55NSF064N
• Device Lot Number: GA024946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 02/17/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown