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

Model Number	60PFSS40
Medical Device Problem Codes	Break (1069); Connection Problem (2900)
Health Effect - Clinical Code	Decreased Respiratory Rate (2485)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number is unknown, information was requested, but was not available from the customer.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 the customer (parent) noticed that the wire was showing, and the tube broken.An emergency tube change was carried out.
Additional Manufacturer Narrative
Other, other text: additional information is provided in d.10., h.2., h.3., and h.6.One photo and three samples without original package.Visual inspection revealed one tube was broken in two parts and the wire was stretched.The other two samples do not present the reported broken tube condition.The event was confirmed.Based on the analysis performed on the photo provided, the event was confirmed, the tube is broken.This type of condition could be generated during use in the patient by stretching the product with excessive force or during reprocessing of sample for subsequent uses due to improper handling or use of non-recommended lubricants or cleaning solutions that could damage the product.Root cause cannot be associated with the manufacturing process since the failure reported could not be reproduced using the tools from assembly process.The failure mode will continue to be monitored, and if a trend is identified an investigation will be conducted.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: BIVONA FLEXTEND PEDIATRIC NEONATAL TRACHEOSTOMY
• 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; 5700 west 23rd ave; gary IN 46406
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; qmc, derby road; minneapolis, MN 55442
• MDR Report Key: 16240878
• Report Number: 3012307300-2023-00659
• Device Sequence Number: 6606052
• Product Code: JOH
• UDI-Device Identifier: 15021312516784
• UDI-Public: 15021312516784
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: Lay User/Patient
• Device Model Number: 60PFSS40
• Device Catalogue Number: 60PFSS40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 01/03/2023
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 01/25/2023
• Supplement Report FDA Received Date: 03/21/2024
• 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
• Patient Weight: 17 KG