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

Model Number	67NFPS30
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pre-test, the cuff was not inflating properly.No patient injury reported.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol b10010116, 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.Visual inspection showed samples were received without their original packaging and with their certificate of safe handling.During functional testing, the samples were filled with 5cc of air according to procedure to see if there was any functional problem.When the samples were inflated with air, the cuff only inflated one side.According to the instruction 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.No root cause could be determined since the complaint was not confirmed since the sample successfully passed the cuff symmetry test.No actions taken.

• Brand Name: SILICONE - BIVONA TUBES NEO/PED FLEXTEND
• 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: 16900360
• Report Number: 3012307300-2023-05447
• Device Sequence Number: 5359467
• Product Code: JOH
• UDI-Device Identifier: 10351688518781
• UDI-Public: 10351688518781
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2023

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 Expiration Date: 04/07/2026
• Device Model Number: 67NFPS30
• Device Catalogue Number: 67NFPS30
• Device Lot Number: 4125806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 05/10/2023
• 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