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

Model Number	60NFPS30
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Insufficient Information (4580); Upper Respiratory Tract Injury (4599)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported via a mhra notification that while is use with a patient, a wire was protruding from an internal aspect of tracheal tube.Also found was a hole in the back on internal aspect of tube.No adverse effects have been reported at this time.
Additional Manufacturer Narrative
Other, other text: b3: date of event, 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
Additional information was received confirming the tube had been in patient use when the error was noted.The tube was about to be repassed into the patient after coming out.It had been cleaned 1 week prior.The patient did experience some airway deterioration including bleeding which required an intensive care stay, however, the reporter was unsure as to whether this was due to this tube directly or other external factors.
Additional Manufacturer Narrative
Email is: regulatory.Responses@icumed.Com.No product or photos were returned therefore no device analysis could be completed.A device history record (dhr) review could not be performed as the lot number was unknown.If the product is returned the manufacturer will re-open the complaint for further device analysis.

• 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: 17211065
• Report Number: 3012307300-2023-06713
• Device Sequence Number: 6391297
• Product Code: JOH
• UDI-Device Identifier: 15021312516685
• UDI-Public: 15021312516685
• 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: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2024

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: 60NFPS30
• Device Catalogue Number: 60NFPS30
• Was Device Available for Evaluation?: No
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 08/01/2023; 01/17/2024
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/16/2023; 02/12/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown