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

Model Number	CMZ3289N
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were no non-conforming reports (ncrs) initiated for the lot or anomalies identified in the device history record (dhr) review.Received one uncuffed fixed custom made tracheostomy tube with swivel connector and a stoma seal.Included was a disconnect wedge, a side port connector, and a red cap for investigation.Visual inspection of the returned device confirmed that the device was made with a rotating neck flange instead of a fixed neck flange.The root cause of the complaint was linked to manufacturing.The drawing was revised to include the note that the neck flange does not rotate.This mdr was generated under protocol b10009704, as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that the custom-made tracheostomy tube is not according to specifications.The fixed flange is not fixed and a ring was added too close to the proximal fome-cuff.No patient injury was reported.

• Brand Name: BIVONA TUBES CUSTOM
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15598755
• Report Number: 3012307300-2022-23869
• Device Sequence Number: 13971119
• Product Code: JOH
• UDI-Device Identifier: 15019517148688
• UDI-Public: 15019517148688
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/13/2022

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
• Operator of Device: Health Professional
• Device Model Number: CMZ3289N
• Device Catalogue Number: CMZ3289N
• Device Lot Number: DS026647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2022
• Initial Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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