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

Model Number	FU21KN40NGE079N
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the mother called this writer and stated that when the trach change was done on (b)(6) 2022, she noted blood on the end of the trach.When she cleaned and touched the end, she noted it was sharp, and the material "white line" appeared to be coming off.
Additional Manufacturer Narrative
Other text: one unit was returned for investigation.Upon physical inspection, it was found that the complained issue could be duplicated.The problem source is unknown.Dhr review was done, no issues related to the original complaint were found.

• Brand Name: BIVONA TUBES CUSTOM
• Common Device Name: TUBE TRACHEOSTOMY 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: 13314617
• Report Number: 3012307300-2022-01336
• Device Sequence Number: 16530586
• Product Code: JOH
• UDI-Device Identifier: 15019517287851
• UDI-Public: 15019517287851
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/17/2022

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
• Device Model Number: FU21KN40NGE079N
• Device Catalogue Number: FU21KN40NGE079N
• Device Lot Number: GA024348
• 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: 01/05/2022
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 03/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown