MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,CUFFED ORAL,SPIRAL-FLEX 7.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-12514
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "(b)(6) 2024, the wire is exposed when using reinforced tracheal intubation and cannot withstand the patient's oral closure pressure under general anesthesia, resulting in tracheal obstruction." another device was used.The patient was reported as fine.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "tube kinked" was confirmed based upon the sample received.Visual examination of the returned sample revealed that the tube was kinked at the proximal end of the tube.The inner part of the tube was occluded due to the kink.It was evident that the returned sample would not pass a kink test based on the extent of the damage.The sample was returned with a bite block on it, but it was not covering the kinked part of the tube.It could not be determined if the bite block was covering the kinked part of the tube when it got damaged.A device history record review was performed on the spiral-flex et tube with no evidence to suggest a manufacturing related cause.The damage observed on the et tube is consistent with damage that can be caused by pinching the tube with high force.It could not be determined what caused the tube to kink, but it could have been caused by the positioning of the patient and/or the patient biting the tube.Based on the location and the type of damage observed, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that: "(b)(6) 2024, the wire is exposed when using reinforced tracheal intubation and cannot withstand the patient's oral closure pressure under general anesthesia, resulting in tracheal obstruction." another device was used.The patient was reported as fine.

• Brand Name: ET TUBE,CUFFED ORAL,SPIRAL-FLEX 7.0
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19390482
• Report Number: 3003898360-2024-00596
• Device Sequence Number: 17881332
• Product Code: BTR
• UDI-Device Identifier: 04026704397310
• UDI-Public: 04026704397310
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K844296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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 Catalogue Number: 5-12514
• Device Lot Number: 73K2100738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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