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

Model Number	FT22GN40NSZ132N
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the balloon was broken.Patient involvement is unknown.
Event or Problem Description
Additional information was received confirming there was no patient involvement, no medical intervention no injury or adverse effects.The outcome of the event was resolved.The event occurred at home.
Additional Manufacturer Narrative
Other, other text: additional information: b5, d4: catalog number, lot number (previously reported as serial number), h6 - health effects codes.H3 and h6 - evaluation codes: updated.Device evaluation: a custom device was received for investigation.Visual inspection identified discoloration and staining from biological matter and damage to the inflation balloon and eyelet.The airway balloon appeared to have been severely chewed; the inflation valve was missing as well as a portion of the silicone that formed the balloon.The eyelet on the right-side when the device is in situ had a tear at the top of the reinforced eyelet that was completely torn through.There was evidence of cuts on the other eyelet that with continued use of a velcro tie would likely propagate into the cut through the reinforced eyelet.The investigation did not identify any manufacturing defects with the returned devices.The cuffs were not damaged and inflated/deflated without issue.The damage identified during the investigation for the device was user inflicted.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No corrective actions are planned at this time.Icu medical regularly analyzes complaint data and trends and will take further 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: 17003822
• Report Number: 3012307300-2023-05657
• Device Sequence Number: 7126152
• Product Code: JOH
• UDI-Device Identifier: 15019517311709
• UDI-Public: 15019517311709
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/10/2023

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: Other
• Device Model Number: FT22GN40NSZ132N
• Device Catalogue Number: FT22GN40NSZ132N
• 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: 05/04/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2023
• 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