MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM 7.0 U/C STANDARD NS; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	SU19IN70ZSZ144N
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 - other: device has not been received to date.Device evaluation: no product sample was received; therefore, visual and functional testing could not be performed.Every custom device is 200 percent inspected for the angle using the specification drawing.The reported issue could not be confirmed.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that trach tube has incorrect curvature.The product was never used.The issue was discovered after comparing the curvature to the other trachs the patient had available.There was no patient involvement and no patient harm/adverse event reported.

• Brand Name: BIVONA CUSTOM 7.0 U/C STANDARD NS
• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18934942
• Report Number: 1824231-2024-00025
• Device Sequence Number: 12484343
• Product Code: JOH
• UDI-Device Identifier: 15019517206401
• UDI-Public: (01)15019517206401(17)280901(10)GB010350
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/19/2024

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: Lay User/Patient
• Device Catalogue Number: SU19IN70ZSZ144N
• Device Lot Number: GB010350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2024
• Initial Report FDA Received Date: 03/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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