MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE, UNCUFFED, 2.5; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN926884
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that, "we are unable to pass a 6 fr.Ballard suction catheter through the 2.5 sheridan hudson rci teleflex ett.We have just intubated a baby and the 5 fr.Inline catheter is also tight".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).Additional information received on 4 july 2023 states that the issue was resolves by using a new tube.The patient required extubation and reintubation.A new suction catheter which was the same size was used as well."baby required reintubation and ett clearance so there was desaturation".The lowest oxygen saturation the patient sustained as "not captured".There was no harm or injury to the patient, the patient status is reported as "stable".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.Corrected data: the initial mdr report submitted on 30 june 2023 shall be updated from reportable malfunction to reportable injury with serious injury as additional information received on 4 july 2023 stated that the patient experienced desaturation.
Event or Problem Description
It was reported that, "we are unable to pass a 6 fr.Ballard suction catheter through the 2.5 sheridan hudson rci teleflex ett.We have just intubated a baby and the 5 fr.Inline catheter is also tight".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Event or Problem Description
It was reported that, "we are unable to pass a 6 fr.Ballard suction catheter through the 2.5 sheridan hudson rci teleflex ett.We have just intubated a baby and the 5 fr.Inline catheter is also tight".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.
Additional Manufacturer Narrative
(b)(4).The reported complaint of "blocked/obstructed - tube" was confirmed based upon the investigation of the sample received.The customer returned one unit 5-10405 et tube, uncuffed, 2.5 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that the tube was cut short.The tube was cut at the "n" of the "oral*nasal" marking towards the proximal end of the device.A non-tfx connector was reinserted into the tube at the proximal end where the tube was cut.The connector most likely belongs to the ballard suction catheter that was used with the returned device.No issues were observed with the et tube itself.It could not be determined how this defect occurred, but this appears to be an isolated event.The angle at which the connector was reinserted could potentially prevent a catheter from passing through the tube smoothly, but this could not be confirmed for this complaint issue.Dhr investigation did not show issues related to complaint.The root cause was undetermined.Teleflex will continue to monitor and trend on this defect.Other remarks: n/a.Corrected data:.

• Brand Name: ET TUBE, UNCUFFED, 2.5
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17240085
• Report Number: 3003898360-2023-00969
• Device Sequence Number: 4834877
• Product Code: BTR
• UDI-Device Identifier: 14026704759313
• UDI-Public: 14026704759313
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/06/2023

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 Expiration Date: 09/23/2024
• Device Model Number: IPN926884
• Device Catalogue Number: 5-10405
• Device Lot Number: 73J1900664
• 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: 06/06/2023
• Supplement Date Received by Manufacturer: 06/15/2023; 01/10/2024
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 07/05/2023; 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2019
• 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
• Patient Sex: Unknown