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

Model Number	CMZ3232S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the pictures confirmed that the eyelet tore.A conversation between the customer service rep and the caregiver revealed that another accessory besides the twill tape that is provided with the device is being used to secure the device to the end user.The ifu, im-gar-10018908-001 (formerly pkg-dfu-cfx-2), states under warnings, ?guard against product damage by avoiding contact with sharp edges.Some tracheostomy tube holders contain velcro or metal clips which may have sharp edges.These sharp edges can come into contact with the eyelets and compromise the product integrity." problem source was traced to user interface.
Event or Problem Description
It was reported that the left eyelet of a patients smiths medical trach tube was split open.No adverse patient effects were reported.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• MDR Report Key: 10552562
• Report Number: 3012307300-2020-09483
• Device Sequence Number: 19533860
• Product Code: JOH
• UDI-Device Identifier: 15019517111606
• UDI-Public: 15019517111606
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/01/2025
• Device Model Number: CMZ3232S
• Device Catalogue Number: CMZ3232S
• Device Lot Number: BS006719
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/18/2020
• 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
• Patient Age: 14 YR
• Patient Weight: 39