MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX TRACHEAL INTUBATION STYLET, 365 MM LENGTH; STYLET, TRACHEAL TUBE

Catalog Number	100/120/300
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	Airway Obstruction (1699)
Date of Event	02/01/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
H3 - other: device has not been received.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
The initial reporter mr.(b)(6)., from (b)(6) stated that they had a life-threatening situation for a patient.When starting the intubation process (noted to be a "difficult intubation"), the device became occupied and stuck without the possibility of removing it from the tube.It was stated that medical intervention was necessary.It was not possible to provide more information regarding the specific medical intervention that occurred.The customer also informed that it is not possible to provide information regarding where the death occurred, what was the status of the patient and they did not provide patient¿s details.Only one sample of this affected batch lot was used in this event.Two products in total were involved.The hospital does not want to provide the information about what kind of tracheal tube was used.According to the head nurse of the ward, (b)(6), the person who performed the intubation was an anesthetist.He did not provide further information about the anesthetist.It is unknown if it was the first time she performed an intubation.(b)(6) commented that it was a difficult intubation during an emergency with an obese patient.They did not use any lubricant due to the speed of the procedure.Medical evaluation: there are two complaints that report a portex intubation stylet was used in a patient and it could not be removed from the endotracheal tube.The report states that the clinical situation led to patient harm and ultimately death.The date of the reported death is (b)(6) 2024.There is no information in the report that states the patient¿s age, gender, medical history or indication for the procedure.The description provided in the report state that the intubation was difficult and the stylet could not be removed from the endotracheal tube.The report also stated that the customer could not provide where the death occurred or other patient details.Lack of details regarding this clinical event or a more detailed description of the clinical event precludes a comprehensive medical assessment.Based on a review of the events in this case, the cumulative evidence does not conclusively implicate or exclude the tracheal intubation stylet as the cause of the patient event, where the stylet could not be removed.If additional information becomes available, this medical assessment update will be further revised as needed.
Additional Manufacturer Narrative
D9 - date device received by manufacturer: 26-feb-2024.H3 and h6 - evaluation codes: updated.Device evaluation: one used sample outside its original package was returned for investigation.Visual inspection found the sample was within specification.No defects were observed.It was also observed that the stylet sample returned was damaged.According to the head nurse of the ward, they did not use any lubricant due to the speed of the procedure.Based on additional information received from customer it was observed that product was not used according to instruction for use for this part number.The item was not lubricated before use.Visual appearance of the part looks like the product was use more that one time.Root cause was not established but possibly related to improper use.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.E1 - address and phone.

• Brand Name: PORTEX TRACHEAL INTUBATION STYLET, 365 MM LENGTH
• Common Device Name: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; carretera miguel alemán km21.7; apodaca nuevo leon ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18926217
• Report Number: 9616567-2024-00046
• Device Sequence Number: 4449819
• Product Code: BSR
• UDI-Device Identifier: 15019315055904
• UDI-Public: (01)15019315055904(17)261129(10)4229955
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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 Catalogue Number: 100/120/300
• Device Lot Number: 4229955
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 03/18/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown