MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA PEDIATRIC TRACHEOSTOMY TUBE 4.0 TTS FLEXTEND STRAIGHT NECK; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	67PFPS55
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 during the routine 3-hourly cuff relief, which involves deflating and reflating balloon with 3.5ml of water patient's mother encountered difficulties with the valve.She stated that the valve was a very tight fit when she inserted the syringe, requiring both her and caregivers to apply significant pressure to the tube.The tube was reported to be used once over a 14-day period.The event happened at the patient's home.There were unknown adverse events reported as a result of the event.
Additional Manufacturer Narrative
H3: the device was received for evaluation.The device history review of the reported lot number found no non-conformities during the manufacturing process.Visual and functional tests were performed.The customer's stated problem was not confirmed.The cuff of the set was observed to being inflating as normal and no difficulties inserting either syringe were observed.There was no known cause of the reported issue, and no further action was taken.

• Brand Name: BIVONA PEDIATRIC TRACHEOSTOMY TUBE 4.0 TTS FLEXTEND STRAIGHT NECK
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana 22425 ; MX 22425
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 21546400
• Report Number: 9617604-2025-00175
• Device Sequence Number: 7605719
• Product Code: JOH
• UDI-Device Identifier: 10351688518576
• UDI-Public: (01)10351688518576(17)281003(10)4434897
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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 Catalogue Number: 67PFPS55
• Device Lot Number: 4434897
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 03/07/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2023
• 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
• Patient Age: 9 YR
• Patient Sex: Male
• Patient Weight: 34 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White