MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM 8.5 A/C HYPERFLEX; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	HA22CS85ZSC036N
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.Device evaluation: one custom 8.5 aire cuff hyperflex device with a proximal foam cuff was received for investigation.Visual inspection by the unaided eye under normal plant lighting did not reveal any defects.Using a syringe, the air was evacuated from the proximal foam cuff and the red plug was sealed.No air reentered the cuff and the cuff remained collapsed.Using the same syringe, 20 cc of air was inserted into the aire cuff.The cuff fully inflated and remained inflated.The device was leak tested.No leaks were detected.The investigation did not confirm the complaint.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 actions taken as no fault found.
Event or Problem Description
It was reported that the trach had a cuff leak.The medical intervention required was to change the trach the next day.The outcome of the event was different trach in and working.Patient had no pre-existing conditions.No harm reported.

• Brand Name: BIVONA CUSTOM 8.5 A/C HYPERFLEX
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 5700 w 23rd ave; gary IN 46406
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18924109
• Report Number: 1824231-2024-00022
• Device Sequence Number: 6410155
• Product Code: JOH
• UDI-Device Identifier: 15019517297584
• UDI-Public: (01)15019517297584(17)280220(10)GB004928
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: HA22CS85ZSC036N
• Device Lot Number: GB004928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown