MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TUBE, TRACHEOSTOMY (W/WO CONNECTOR); SILICONE - BIVONA TUBES NEO/PED AIRE-CUF

Model Number	65SP045
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that uring use, the patient pulled the inflation line and tore it.No patient injury.
Additional Manufacturer Narrative
Other text: this remediation mdr was generated under protocol (b)(4) as a result of warning letter cms#(b)(4).Five pictures and two samples were received for evaluation.Based on the pictures, the condition reported is visible.The samples were received in used condition, without it's original packaging and with its certificate of safe handling.The sample was visually inspected under normal lighting and the condition reported in the complaint is visible; however, this does not assure us that there is still a failure of the process, since mishandling by the user by not using the tracheostomy device correctly can cause the rupture.Based on this the complaint cannot be confirmed.It is not perceived that the device has been disassembled or that the device has had any cut before being installed in the patient.Based on investigation results, the root cause is the damage occurred after the product the manufacturing facility.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process., corrected data: d1 and d2.

• Brand Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Common Device Name: SILICONE - BIVONA TUBES NEO/PED AIRE-CUF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 west 23rd ave; gary IN 46406
• Manufacturer (Section G): NULL; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 3-10-15, hakata station east,; minneapolis, MN 55442
• MDR Report Key: 12978693
• Report Number: 3012307300-2021-12612
• Device Sequence Number: 4883432
• Product Code: JOH
• UDI-Device Identifier: 15021312000313
• UDI-Public: 15021312000313
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 65SP045
• Device Catalogue Number: 65SP045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/11/2021
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown