MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCHELIT PREFORMED NASAL TRACHEAL TUBE, CUFF; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	IPN041457
Medical Device Problem Codes	Inflation Problem (1310); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "incident occurred on (b)(6) 2025.Patient was intubated; pilot balloon was unable to inflate (walls of the pilot balloon stuck together).As a result, tube was removed and intubation repeated.There were no clinical consequences or desaturation for the patient.There was only a delay in treatment.The patient left the hospital on the day as scheduled on (b)(6) 2025.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of 'pilot balloon was unable to inflate' was confirmed upon investigation of the returned sample.The customer returned the actual sample for investigation.Visual examination of the returned device revealed no abnormalities.Functional inspection identified the valve was stuck to the wall of the pilot balloon, and the surface of the pilot balloon appears narrowed, making it very difficult to insert the endotest for the inflation test.Additionally, the cuff cannot be inflated because the valve appears to be broken.A sample from production was taken for simulation to replicate the defect, and no defects were replicated.A review of the manufacturing process confirmed that the tracheal tubes undergo 100% visual inspection and inflation test during final inspection, as part of the product release criteria.Any such defects would be detected as out of specification.The nature of the damage suggests it was not caused by a manufacturing process failure.A device history record review was performed, and no relevant findings were identified.Based on the investigation, the exact root cause of this reported issue was undetermined.No manufacturing related root cause identified for this event.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that: "incident occurred on (b)(6) 2025.Patient was intubated; pilot balloon was unable to inflate (walls of the pilot balloon stuck together).As a result, tube was removed and intubation repeated.There were no clinical consequences or desaturation for the patient.There was only a delay in treatment.The patient left the hospital on the day as scheduled on (b)(6) 2025.".

• Brand Name: RUSCHELIT PREFORMED NASAL TRACHEAL TUBE, CUFF
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21629149
• Report Number: 8040412-2025-00072
• Device Sequence Number: 12849514
• Product Code: BTR
• UDI-Device Identifier: 04026704325634
• UDI-Public: (01)04026704325634(11)241030(17)290930(10)40E24K5691(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN041457
• Device Catalogue Number: 111782-000060
• Device Lot Number: 40E24K5691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown