MAUDE Adverse Event Report: ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V. BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	60SP040
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 phone number: (b)(6).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 there were holes in the shaft.The staff noticed holes prior to cleaning trach for 1st reprocessing.
Additional Manufacturer Narrative
D4 - expiration date and d4 - primary udi number: correction.H6.Codes: updated.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.
Event or Problem Description
An email was received regarding a 4.0 uncuffed pediatric tracheostomy tube 1/ea with list number 60sp040 and lot number 6063394.It was stated that there were holes in the shaft.Trach was sent to mdrd for reprocessing post trach change ¿ mdrd staff noticed holes prior to cleaning trach for 1st reprocessing in mdrd.Additional information received august 21, 2025, with updated lot number.
Additional Manufacturer Narrative
D4 - primary udi number: correction from (b)(4).D4.Lot number no product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review showed there were no discrepancies or non-conformances during the manufacturing of the reported lot number.If the product is returned the manufacturer will re-open the complaint for further device analysis.
Additional Manufacturer Narrative
D9: date returned to mfg: 9/30/2025.Device evaluation: one used device was received for device analysis.Service history review identified the complaint was not related to a previous service of the device within the review period.Functional testing and visual inspection performed during analysis.The customer reported complaint was confirmed and a hole in the shaft was found.The probable root cause could not be identified.
Additional Manufacturer Narrative
D3: mfr establishment name: icu medical healthcare manufacturing s.A.De c.V.D4: lot #; 6063394.D4: expiration date; 10/20/2029.D4: primary udi: (b)(4).E1: initial reporter phone.(b)(6).

• Brand Name: BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): ICU MEDICAL HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 22302556
• Report Number: 3012307300-2025-07461
• Device Sequence Number: 8025773
• Product Code: JOH
• UDI-Device Identifier: 15021312000382
• UDI-Public: (01)15021312000382(11)291020
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083641
• 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,Followup,Followup,Followup
• Report Date (Section B): 04/01/2026

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: Other
• Device Catalogue Number: 60SP040
• Device Lot Number: 6063394
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 06/23/2025; 08/21/2025; 10/31/2025; 03/10/2026
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/16/2025; 08/22/2025; 11/20/2025; 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/23/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown