MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. PORTEX SACETT SUCTION ABOVE CUFF ENDOTRACHEAL TUBE; TUBE, TRACHEAL (W/WO CONNECTOR)

Catalog Number	100/189/070
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Sore Throat (2396); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 "during extubation of a patient in the icu, the tube got stuck and could not be pulled out.The attempt was paused until the next day and decongestive treatments were administrated.The following day, during a successful extubation, it was observed that the cuff in the tube had settled like a functional collar and therefore could not be pulled out.With some further adjustment, the resistance felt lessened, and the tube was removed and replaced over a guidewire with a tube size 6.After 3 hours, the patient was extubated without complications.Upon inspection of tube size 7, a cone-shaped collar was observed that created relatively high resistance to extubation as it hooked under the vocal cords.The patient became significantly hoarse and had to spend an unnecessary extra day on the ventilator.It is unknown whether the patient has sustained permanent damage requiring follow-up with ent".
Additional Manufacturer Narrative
H6.Investigation codes: updated.Investigation summary: received one (1) used.List #100/189/070, sacett, suction above cuff tracheal tube.As received, there were no damages or anomalies observed.In order to replicate clinical use, the cuff was fully inflated with 20ml of air with an icu medical provided syringe.No leaks were observed.The cuff was then deflated in the same manner with no difficulty.The complaint of removal difficulty cannot be confirmed nor replicated.A device history record could not be completed as no lot number was received.

• Brand Name: PORTEX SACETT SUCTION ABOVE CUFF ENDOTRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20739444
• Report Number: 9617604-2024-00888
• Device Sequence Number: 15547858
• Product Code: BTR
• UDI-Device Identifier: 15019315059520
• UDI-Public: (01)15019315059520(17)270902(10)4325737
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: 100/189/070
• Device Lot Number: 4325737
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BETAPRED; LOCAL ADRENALINE; MUSCLE RELAXANT; XYLOCAINE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown