MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number	60P040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Discomfort (2330); Insufficient Information (4580)
Date of Event	04/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event; d4: lot number, expiration date and h4: device manufacture date is 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 by a patient that a bivona non-flextend tracheostomy tube was faulty.The patient reported feeling like "something was stuck in his throat".The parent and nurse reported that tears were observed upon manipulating the tube without the introducer.No adverse effects reported.
Additional Manufacturer Narrative
Other, other text: b3 and b5, updated.
Event or Problem Description
Additional information received via email.The exact date is not clear, but it was the weekend of the (b)(6) 2023 and was while in situ with the patient.The patient reported "feeling as if something was stuck in his throat while the trache tube was in situ".
Additional Manufacturer Narrative
Email is: regulatory.Responses@icumed.Com.One device sample was received in used condition without the original packaging.Per visual inspection, the samples showed tears along the length of the tube.The complaint was confirmed.Based on the analysis performed this type of condition can be generated during the handling of the product in the intubation process or the use of non-recommended lubricants or cleaning solutions, the root cause was attributed to the supplier and could not be associated to the manufacturing process since the reported failure could not be reproduced using the assembly process tools.A device history record (dhr) review could not be performed as the lot number was unknown.No corrective actions were taken since the investigation did not reveal that the defect was caused during the manufacturing process.

• Brand Name: BIVONA TRACHEOSTOMY TUBE, NEONATAL/PEDIATRIC
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• 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: 17004682
• Report Number: 3012307300-2023-05668
• Device Sequence Number: 6286650
• Product Code: JOH
• UDI-Device Identifier: 15021312005752
• UDI-Public: 15021312005752
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 60P040
• Device Catalogue Number: 60P040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/09/2023
• Supplement Date Received by Manufacturer: 07/14/2023; 01/23/2024
• Initial Report FDA Received Date: 05/25/2023
• Supplement Report FDA Received Date: 07/21/2023; 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown