MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOMIZED TRACHEOSTOMY TUBES; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	FU23BN60NGF974N
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event and lot number, expiration date, udi section and manufacture date are unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when required.
Event or Problem Description
It was reported that there was a cosmetic flow in the silicone.The patients mother states that they are able to rub their finger over the blemish and feel it.No patient harm reported.
Additional Manufacturer Narrative
Other, other text: d10 device available for evaluation and h6 evaluation codes: updated device evaluation: one device was submitted for investigation.Visual inspection confirmed the presence of excess adhesive and scratches.The complaint was confirmed.Based on device analysis the observed excess adhesive on the shaft was confirmed as a manufacturing nonconformance.It is highly probable to have occurred during the manual assembly process; specifically at the stage in which the connector/neck flange sub-assembly is adhered to the shaft.Potential root causes for the scratches noted on the shaft are consistent with aggressive scrubbing of the tube, use of hard bristled brushes, or sharp wire mounted swabs during reprocessing and post-manufacturing.This goes against instructions for use.A review of manufacturing records confirmed that only one lot number has been manufactured to date for the affected part number.A lot number was not reported by the customer, however the device history record (dhr) for the found lot number was reviewed and found to meet all requirements for release with no non-conformities related to the complaint.No corrective actions will be conducted by the manufacturing facility at this time.Complaint reviews were conducted which confirmed that no other complaints for this lot have been received.Complaint information will continue to be monitored., corrected data: b3, b5, h6 health effects codes.
Event or Problem Description
Additional information was received correcting information previously reported.The customer reported that the patient did not know the lot number of the product.The event occurred with the patient.There was no medical intervention.The outcome of the event was reported as still ongoing.The event occurred at patient/home.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16798255
• Report Number: 3012307300-2023-04458
• Device Sequence Number: 6386729
• Product Code: JOH
• UDI-Device Identifier: 15019517335446
• UDI-Public: 15019517335446
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2023

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: Lay User/Patient
• Device Model Number: FU23BN60NGF974N
• Device Catalogue Number: FU23BN60NGF974N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/04/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR
• Patient Sex: Unknown
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White