MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA TRACHEOSTOMY TUBE, NEONATAL PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	60SP050
Medical Device Problem Codes	Break (1069); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the neck holder hole on the pediatric tracheostomy tube collar was broken.There was patient involvement; however, no patient harm was reported.
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.The investigation included root cause, and analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.
Additional Manufacturer Narrative
D3: updated.G4: updated.H3 and h6 codes: updated.One (1) used sample was received for evaluation.A lot of history review was conducted, and no nonconformities were identified that could have contributed to the reported complaint.Visual inspection revealed that the flange eyelet was torn, with an irregular and uneven tear pattern observed.The reported customer issue was confirmed.However, based on the available evidence, the probable root cause could not be determined.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL PEDIATRIC
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 25128565
• Report Number: 3012307300-2026-04715
• Device Sequence Number: 15646273
• Product Code: BTO
• UDI-Device Identifier: 15021312000405
• UDI-Public: (01)15021312000405(17)291008(10)6059014
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K912469
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: Lay User/Patient
• Device Catalogue Number: 60SP050
• Device Lot Number: 6059014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2024
• 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