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

Model Number	60NFP30
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 required.
Event or Problem Description
It was reported that the customer reported a damage tracheostomy tube.The trach had been sterilized once previously and was being changed to the end of its second use.Had been in place for one month when the damage was noticed by the patient's mother.The device was changed to a trach that had been sterilized twice, this was it's third use.The trach was checked prior to insertion and found to be sufficient for placement.A picture was sent in from the customer showing possible chipping of the trach ties.Exact "damage" has not bee communicated.
Additional Manufacturer Narrative
Other, other text: additional information is provided for d.10, h.2, h.3, and h.6.Two samples and one photo received for evaluation.Visual inspection revealed the device was received in used conditions without the original packaging; it was detected that the flange was damaged in both samples.Functional testing was performed, and the reported issue was able to be replicated.The root cause was determined to be user interface.Device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.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.D.4 full udi number: (b)(4).

• Brand Name: BIVONA FLEXTEND PEDIATRIC AND NEONATAL TRACH 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: 16856098
• Report Number: 3012307300-2023-04929
• Device Sequence Number: 20525898
• Product Code: JOH
• UDI-Device Identifier: 15021312014723
• UDI-Public: 15021312014723
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2024

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 Expiration Date: 08/17/2025
• Device Model Number: 60NFP30
• Device Catalogue Number: 60NFP30
• Device Lot Number: 4023787
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2020
• 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: 8 MO
• Patient Sex: Unknown
• Patient Weight: 8 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian