MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	67SP035
Medical Device Problem Codes	Inflation Problem (1310); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Decreased Respiratory Rate (2485); Respiratory Insufficiency (4462)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3: date of event, d4: lot number, expiration date and h4: manufacture date are unknown, no information has been provided 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 there were two different issues.1st.New trach tubes intermittently required additional water and massaging before use.2nd.New trach tubes were found?.Defective" in that water did not enter the line to the cuff from the balloon.Each fault has caused a delay in resuscitation during a critical change in which cpr was required.The customer reported lot number 34180462; which cannot be verified.
Additional Manufacturer Narrative
No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review could not be performed as the lot number was unknown.If the product is returned the manufacturer will re-open the complaint for further device analysis.
Additional Manufacturer Narrative
Other, other text: the product's history records were reviewed and there were no non-conformances that would have resulted in the reported complaint.

• Brand Name: BIVONA NEONATAL AND PEDIATRIC TTS TRACHEOSTOMY TUB
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• 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: 17165119
• Report Number: 3012307300-2023-06376
• Device Sequence Number: 5757278
• Product Code: JOH
• UDI-Device Identifier: 15021312000719
• UDI-Public: 15021312000719
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K083641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 67SP035
• Device Catalogue Number: 67SP035
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 10/25/2023; 01/08/2024
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 11/16/2023; 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 7 MO
• Patient Sex: Male
• Patient Weight: 5 KG