MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Catalog Number	65SP025
Medical Device Problem Codes	Crack (1135); Fitting Problem (2183); Connection Problem (2900)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: 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 while in use with a patient, the device had a damaged/cracked connector.Adverse effects have not been reported.
Additional Manufacturer Narrative
Other text: d3, g1, and g2 email is: regulatory.Responses@icumed.Com.H3 and h6 - evaluation codes: updated.Device evaluation: one device and two photos were returned for investigation.The photos showed damaged components in the complaint sample.Visual inspection found that the pilot valve was damaged.The complaint was confirmed.Based on the analysis conducted in the sample provided, the pilot valve presents a damage.Root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly and packaging process.No lot number was provided therefore the device history report (dhr) review could not be performed.No corrective action is required because the failure mode reported could not be reproduced using the tools from assembly and packaging process inside of the manufacturing facility.

• Brand Name: BIVONA AIRE-CUF PEDIATRIC TRACHEOSTOMY TUBE
• 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: 17480939
• Report Number: 3012307300-2023-07865
• Device Sequence Number: 21017994
• Product Code: JOH
• UDI-Device Identifier: 15021312000276
• UDI-Public: 15021312000276
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K914088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2023

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 Catalogue Number: 65SP025
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 11/26/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 12/15/2023
• 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
• Patient Sex: Unknown