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

Model Number	67P030
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuff is sticking during pre-test.No patient injury was reported.
Additional Manufacturer Narrative
This mdr was generated under protocol b10010116, as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.When the sample 1 was inflated with air, the cuff only inflated one side.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.Sample 2 did not present the reported condition, based on analysis the complaint is not confirmed.No root cause was not determinate since the complaint was not confirmed.No actions were taken since the complaint was not confirmed.No problems or issues were identified during this device history record review.E4: initial reporter also sent report to fda is unknown.

• 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
• Manufacturer Contact: jim vegel
• MDR Report Key: 16910127
• Report Number: 3012307300-2023-05532
• Device Sequence Number: 20723506
• Product Code: JOH
• UDI-Device Identifier: 15021312006254
• UDI-Public: 15021312006254
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K944178, K08
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• 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: 67P030
• Device Catalogue Number: 67P030
• Device Lot Number: 3683537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• 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: 04/27/2023
• Initial Report FDA Received Date: 05/11/2023
• 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