MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE,CF,4.0; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048866
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the cuff did not inflate during pretest before use".No patient involvement reported.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of failure mode reported in the current manufacturing process was conducted as follows: 125 samples were taken from the current production; the samples were visually inspected, and issue reported "unable to inflate - cuff" was not observed in the current manufacturing process.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.
Event or Problem Description
It was reported that "the cuff did not inflate during pretest before use".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The customer returned one unit 5-10108 et tube,cf,4.0 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that the inflation line was loose from the tube.The notch on the tube appears slightly stretched upward, which is an indication that the inflation line might have been pulled out of the tube.Functional inspection could not be performed due to the condition of the returned sample.The manufacturing site was consulted for this investigation.It could not be determined what caused this issue to occur.Since the sample was returned out of its original packaging, it could not be confirmed if the inflation line was loose when it left manufacturing.Et tubes are 100% tested at manufacturing for proper inflation, so it is unlikely that the inflation line was loose at the time of manufacturing.This appears to be an isolated issue.The ifu for this product states, "the tracheal tube cuff inflation system, including the valve, should be checked prior to intubation.If a malfunction is a detected in any part of the system, the tube should not be used." "care should be taken to avoid damaging the thin-walled cuffs during intubation.If cuff is damaged, the tube should not be used." the reported complaint was confirmed based upon the sample received.The inflation line of the returned et tube was returned loose from the et tube.The notch on the tube appears slightly stretched upward, which is an indication that the inflation line might have been pulled out of the tube.The manufacturing site was consulted for this investigation.It could not be determined what caused this issue to occur.Since the sample was returned out of its original packaging, it could not be confirmed if the inflation line was loose when it left manufacturing.A device history record review was performed with no evidence to suggest a manufacturing related cause.All et tubes are 100% inspected for inflation and deflation at the time of manufacturing.It is unlikely that this type of damage was present at the time of manufacturing.Therefore, the root cause of this complaint is unknown.This appears to be an isolated issue.

• Brand Name: HUDSON ET TUBE,CF,4.0
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13931739
• Report Number: 3003898360-2022-00072
• Device Sequence Number: 11944963
• Product Code: BTR
• UDI-Device Identifier: 14026704616456
• UDI-Public: 14026704616456
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K822082
• 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): 03/07/2022

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
• Device Expiration Date: 08/02/2026
• Device Model Number: IPN048866
• Device Catalogue Number: 5-10108
• Device Lot Number: 73H2100146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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: N/A.; N/A.
• Patient Sex: Unknown