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

Model Number	XU18IS75NSC191N
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).The reported issue could not be confirmed as no product sample was received for evaluation.A review of the pictures showed that the wires were moved out of position.This happens when the shaft is either pulled / stretched, which breaks the silicone support between the wires, or when the shaft is scrubbed excessively, and the cleaning implement pulls the wires out of place causing the wires to not be supported.Without the sample, no other determinations can be made.No adverse trends have been identified related to this issue.No corrective actions are planned at this time.Complaint data and trends are regularly analyzed.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Event or Problem Description
It was reported that during cleaning and inspection, it was found that the extended trachea part is kinked.No patient injury reported.

• Brand Name: SILICONE - 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16882784
• Report Number: 3012307300-2023-05244
• Device Sequence Number: 20289257
• Product Code: JOH
• UDI-Device Identifier: 15019517165883
• UDI-Public: 15019517165883
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2023

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 Model Number: XU18IS75NSC191N
• Device Catalogue Number: XU18IS75NSC191N
• 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: 04/28/2023
• Initial Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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