MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA CUSTOM TIGHT TO SHAFT STANDARD, 5.5, HYPERFLEX; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	HT18FS55NSB094S
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown, no information has been provided to date.D4: lot number, expiration date, full udi, and h4: manufacture date are not available based on the reported lot number.E1 - additional reporter phone number: (b)(6).H3 - other: device has not been returned 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 device had a difficult time inflating and deflating the cuff.The cuff would not deflate quickly enough.There was no patient involvement and no harm/adverse event reported.The reported lot number gbdd7416, cannot be verified.
Additional Manufacturer Narrative
D9.Date returned to mfg: 14-may-2024.H6.Investigation codes: updated.Investigation summary: received one custom 5.5 hyperflex device for evaluation.Visual inspection of the returned sample by the unaided eye under normal plant lighting revealed that the inflation valve had been pushed inside the inflation balloon.The balloon was inspected, and no cuts or tears were present that would have contributed to the inflation valve migrating to the inside of the balloon.The inflation valve was reseated to its normal position.Using a syringe 5 cc of air was inserted into the valve.The cuff inflated and remained inflated.The air was evacuated, and the device was leak tested.No leaks were detected.The inflation valve does not require a twisting motion or a large amount of force to activate the valve.It is likely that a twisting motion or excessive force was applied to the inflation valve when attaching the syringe, which moved the valve further into the balloon.When the valve is not seated in its normal position, there is a gap, which prevents the inflation system from being closed / operating as designed.Customized devices are 200% inspected for valve placement per wi-09-0310-23 and 200% leaked tested, which requires the valve to be secured properly in the balloon.The investigation did not identify a manufacturing defect with the device.No corrective actions are planned at this time.A device history record could not be completed as no lot number was received.

• Brand Name: BIVONA CUSTOM TIGHT TO SHAFT STANDARD, 5.5, 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: 19264068
• Report Number: 1824231-2024-00046
• Device Sequence Number: 11434277
• Product Code: JOH
• UDI-Device Identifier: 15019517156003
• UDI-Public: (01)15019517156003
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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: Other
• Device Catalogue Number: HT18FS55NSB094S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 06/02/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown