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

Model Number	67P040
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#617147.No problem or issues were identified during the device history record review.One used sample was received without its original packaging, with the certificate of safe handling and the obturator.The sample was visually inspected under normal lighting to detect any damage on the cuff.No discrepancies were found.During functional testing, the sample was inflated with air using a 5 ml syringe, after that the cuff was gently manipulated.The whole cuff was inflated without abnormalities.It was demonstrated that the cuff was symmetrical, and no leak was detected.Complaint is not confirmed.No root cause was determined due complaint was not confirmed.No corrective actions required since the complaint was not confirmed.
Event or Problem Description
It was reported that during cuff testing before use, cuff would not completely inflate.Cuff was manipulated just as stated in product's instructions for use but issue was not resolved.Use of another tracheostomy tube to resolve issue.No patient injury reported.

• 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: 16882727
• Report Number: 3012307300-2023-05239
• Device Sequence Number: 12576925
• Product Code: JOH
• UDI-Device Identifier: 15021312006278
• UDI-Public: 15021312006278
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2023

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: 04/11/2023
• Device Model Number: 67P040
• Device Catalogue Number: 67P040
• Device Lot Number: 3625204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• 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: 05/05/2023
• 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