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

Catalog Number	FT23AN45NSF976N
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: b3: date of event is 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 additional reportable information becomes available.
Event or Problem Description
It was reported that there was "some debris and possible mold in/on the custom tracheostomy".Patient involvement unknown.
Additional Manufacturer Narrative
Other, other text: d10.Device available for evaluation, h3.Device evaluated by manufacturer and h6.Evaluation codes: updated.D3, g1,2 email is: regulatory.Responses@icumed.Com.Four tracheostomy tubes with swivel connectors, long straight pediatric neck flanges and obturators were received without packaging, as well as two photos and a video were returned for analysis.All four devices displayed varying degrees of dried blood and loose fibrous material between the swivel connector inner diameter (id) and shaft outer diameter (od).Surface microbiological testing was performed on the devices surfaces where the fibrous material was noted.Test results confirmed presence of bacteria on the devices without mold present, which was most probable to be due to the decontamination process prior to this investigation.Photos were consistent with sample four; however, the video could not be opened due to software incompatibility.The potential sources for the fibrous material during use include the tracheostomy dressing or third-party tube holder material that can get caught between the swivel connector and shaft of the device, dressing and/or tube holder shifts during use (material is not consistent with the supplied twill tape).Potential sources for the fibrous material during cleaning process include the use of non-lint free cleaning materials.Root cause for mold growth during use may potentially be related to variations in cleaning and storage technique; specifically, mold is likely to grow if the devices were not completely dried prior to storage per instructions for use (ifu).Without information about the cleaning method, storage conditions or the number of re-processing cycles, no definitive root cause can be determined with confidence.Based on the device analysis, the complaint cannot be confirmed as a manufacturing nonconformance, but is highly probable to be related to a variation in technique.A device history record (dhr) review reported no discrepancies or non-conformances during the manufacturing of the reported lot number.Since the reported event could not be verified and/or confirmed with confidence, no further actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored and corrective/ preventative actions accordingly.

• Brand Name: BIVONA CUSTOMIZED TRACHEOSTOMY TUBES
• 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: 18049533
• Report Number: 3012307300-2023-10128
• Device Sequence Number: 7500021
• Product Code: JOH
• UDI-Device Identifier: 15019517329131
• UDI-Public: 15019517329131
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/04/2024

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 Catalogue Number: FT23AN45NSF976N
• Device Lot Number: ST016486
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2023
• 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 Sex: Unknown