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

Model Number	HA14GS80NSC315N
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, 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 upon using the trach, it was defective.A second trach was used, and it was defective as well.After applying 24cc of air, it was able to displace one side of the cuff, but the other side continued to be adhered and required an additional 36cc-48cc of air and would not displace.Placed multiple syringes of saline to displace and that would not work either.After placing 36-48 cc of air with a lot of pressure applied to manipulate the cuff off the trach and it was able to displace the cuff off the trach shaft.It was the same issue in the 2nd trach.The nurse borrowed a trach from the hospital to resolve the situation.No injury was reported.(cc-0192752 documents that first item and cc-0192849 documents the second item).
Additional Manufacturer Narrative
Device evaluation: two custom trachs were returned for investigation.Upon visual inspection portions of the cuffs were flat against the shaft.No other concerns were identified.During functional testing the cuff inflated except for one area.Using a verified ruler the stuck area extended 25 mm parallel to the shaft (approx.7 mm from the distal cuff band and 3 mm from the proximal cuff band) and 2 mm wide.Following normal protocol (i.E., squeeze the pilot balloon while massaging the cuff away from the shaft), the cuff fully inflated.Once the stuck portions of the cuffs were released, the cuffs were inflated and deflated multiple times without an issue.The devices were allowed to rest with the air removed from the cuffs for 18 hours.Using a syringe, 10 ml of air was inserted into the inflation valve of both devices.The cuffs on both devices fully inflated without any portion of the cuffs sticking to the shaft.The complaint could no be confirmed.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.

• 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: 16797101
• Report Number: 3012307300-2023-04455
• Device Sequence Number: 16928711
• Product Code: JOH
• UDI-Device Identifier: 10351688761644
• UDI-Public: 10351688761644
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2023

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 Model Number: HA14GS80NSC315N
• Device Catalogue Number: HA14GS80NSC315N
• Device Lot Number: GA024358
• 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: 06/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2021
• 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