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

Model Number	750170
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2022
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 problem or issues were identified during the device history record review.Four (4) pictures were attached and reviewed.Picture one; shows the top of a box for the tracheostomy tube with insertion and removal dates written.Picture two; shows an open tray of a tracheostomy tube with label information.Picture three; shows the side label of a box for tracheostomy tube with product information.Picture four ; shows a tracheostomy tube with its obturator.No sign of failure reported.Per the attached pictures, the complaint cannot be confirmed.Functional testing could not be performed as no product was returned for analysis.No root cause could be determined, no action taken.
Event or Problem Description
It was reported, that there was a respiratory issue.Tube inserted on (b)(6) 2022 and removed on (b)(6) 2022.Same patient as complaint files (b)(6).No patient injury reported.

• Brand Name: SILICONE - BIVONA TUBES ADULT AIRE-CUF
• 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: 16915817
• Report Number: 3012307300-2023-05606
• Device Sequence Number: 20471822
• Product Code: JOH
• UDI-Device Identifier: 15021312006414
• UDI-Public: 15021312006414
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• 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: Health Professional
• Device Model Number: 750170
• Device Catalogue Number: 750170
• Device Lot Number: 4136191
• 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: 05/01/2023
• Initial Report FDA Received Date: 05/11/2023
• 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 Age: 48 YR
• Patient Sex: Male
• Patient Weight: 65 KG