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

Model Number	67P055
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that cuff doesn't inflate properly during pre-test.No patient injury was reported.
Additional Manufacturer Narrative
Other, other text: this remediation mdr was generated under protocol (b)(4) , as a result of warning letter cms#(b)(4).No problem or issues were identified during the device history record review.Two samples were received for evaluation.The samples were received in used conditions, without original packaging and with its certificate of safe handling.During functional testing, the samples were filled with 5cc of air according to procedure.When the samples were inflated with air, the cuff only inflated one side.As per the instructions for use, the pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the times the cuff inflated completely and symmetrically, based on analysis the complaint is not confirmed.Root cause could not be determined since the sample successfully passed functional test.No corrective actions were taken since the complaint was not confirmed.

• Brand Name: SILICONE - BIVONA TUBES NEO/PED TTS
• 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; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13714450
• Report Number: 3012307300-2022-04424
• Device Sequence Number: 6373671
• Product Code: JOH
• UDI-Device Identifier: 15021312006308
• UDI-Public: 15021312006308
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2023

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: 67P055
• Device Catalogue Number: 67P055
• Device Lot Number: 8124566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 05/04/2023
• 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