MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA; TRACHEOSTOMY TUBES

Model Number	67PFPS60
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cuffs did not inflate.The customer stated that the product was defective.There were no reports of patient harm or impact associated with the reported event.
Additional Manufacturer Narrative
G3: report source: no information was provided and is unknown.H10: this remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).Visual and functional testing was performed.Two samples were received in used conditions, without original packaging and with its certificate of safe handling.When the sample was inflated with air, the cuff only inflated one side, the pilot balloon was manipulated, and the cuff inflated.After the whole cuff inflated, it was deflated and inflated 4 times, all the time the cuff inflated completely and symmetrically, based on analysis the complaint is not confirmed.The root cause was not determined as the function sample passed functional testing.

• Brand Name: BIVONA
• Common Device Name: TRACHEOSTOMY TUBES
• 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: 16861469
• Report Number: 3012307300-2023-04976
• Device Sequence Number: 12211425
• Product Code: JOH
• UDI-Device Identifier: 10351688518583
• UDI-Public: 10351688518583
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K923878
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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: 67PFPS60
• Device Catalogue Number: 67PFPS60
• Was Device Available for Evaluation?: No
• 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: 08/24/2021
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown