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

Catalog Number	60PFSS35
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other, other text: 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 the customer experienced a broken tracheostomy tube.The event resulted in an emergency tracheostomy tube change.Patient involvement but no patient or clinical injury.
Additional Manufacturer Narrative
One device was returned for investigation in used conditions without the original packaging.Visual inspection confirmed the customer complaint that shaft was separated from the connector, it was seen that the whole adhesive was attached to the connector.During the manufacturing process, devices are routinely inspected for quality assurance.Investigators went through the manufacturing process and were not able to duplicate the reported issue with any of the manufacturing tools used during the assembly process.Based on the analysis conducted and the customer report, it presents damage which can be caused by excessive manipulation or cutting with a tool; the assembly process was reviewed in which no sharp tools are used and there is no way to cause damage manually.A device history (dhr) review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.

• Brand Name: BIVONA FLEXTEND NEONATAL AND PEDIATRIC TRACHEOSTOM
• 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: 17795106
• Report Number: 3012307300-2023-09196
• Device Sequence Number: 2251149
• Product Code: JOH
• UDI-Device Identifier: 15021312516777
• UDI-Public: 15021312516777
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 60PFSS35
• Device Lot Number: 4322679
• 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: 09/01/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2022
• 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: 24 MO
• Patient Sex: Male
• Patient Weight: 13 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White