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

Catalog Number	ST18LN65NSC990N
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that the device tube was bent to one side.The event occurred upon opening at the patient's home.There was no medical intervention required.There was no patient involvement and no patient harm/adverse event reported.
Additional Manufacturer Narrative
H3:.Reason device not evaluated by mfg: other.Device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56, when additional reportable information becomes available.
Additional Manufacturer Narrative
Investigation summary: the affected device was returned for evaluation.A visual inspection by the unaided eye under normal plant lighting confirmed that the shaft was skewed slightly to the right.Cause not established.A device history record could not be completed as no lot number was received.A quality alert was issued to heighten awareness of the issue to the custom lab operators and quality inspectors.

• Brand Name: BIVONA CUSTOM FIXED TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19838607
• Report Number: 1824231-2024-00062
• Device Sequence Number: 7594903
• Product Code: JOH
• UDI-Device Identifier: 15019517173796
• UDI-Public: (01)15019517173796(17)290126(10)GB016190
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ST18LN65NSC990N
• Device Lot Number: GB016190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 08/25/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown