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

Model Number	60SP035
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(6).No problems or issues were identified during the device history record review.Two samples were received in used conditions, with their certificate of safe handling and without original packaging.Both samples were mounted on the fixture to check the tube tilt.Sample one had a tilt to the right, but it was within the acceptance range.Sample two was tilted to the left, however, it was within the acceptance range.Based on this the complaint cannot be confirmed.The complaint was not confirmed.No root cause could be determinate since the samples successfully passed the cuff tilt test.No corrective actions were taken since the complaint was not confirmed.
Event or Problem Description
It was reported, that during the pre-test.The customer found two trach tubes with slight curves on them.No patient injury was reported.

• Brand Name: SILICONE - BIVONA TUBES NEO/PED
• 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: 16915387
• Report Number: 3012307300-2023-05575
• Device Sequence Number: 2189100
• Product Code: JOH
• UDI-Device Identifier: 15021312000375
• UDI-Public: 15021312000375
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2023

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 Expiration Date: 03/27/2024
• Device Model Number: 60SP035
• Device Catalogue Number: 60SP035
• Device Lot Number: 3828296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2019
• 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