MAUDE Adverse Event Report: TELEFLEX MEDICAL ET TUBE,CF,8.0; TUBE, TRACHEAL (W/WO CONNECTOR

Catalog Number	5-10116
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the cuff didn't inflate when intubating the tube to the patient.Therefore, the tube was replaced with a new one.No injury to the patient was reported." no patient harm or injury.The patient status is reported as "fine".
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 "the cuff didn't inflate when intubating the tube to the patient.Therefore, the tube was replaced with a new one.No injury to the patient was reported." no patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one unit 5-10116 et tube,cf,8.0 for investigation.The et tube was visually examined with and without magnification.Visual examination of the returned device revealed that the sample had a hole in the middle of the balloon cuff which would prevent the cuff from inflating.No other defects or anomalies were observed.The sample was submerged underwater and an attempt was made to inflate the device in order to detect any additional leaks.Upon injection of air, the device only leaked from the hole in the balloon cuff.A device history record review was performed and no relevant findings were identified.The sample was submerged underwater and an attempt was made to inflate the device in order to detect any additional leaks.Upon injection of air, the device only leaked from the hole in the balloon cuff.The reported complaint was confirmed based upon the sample received.The returned et tube was found to have a hole in the balloon cuff which prevented it from being able to stay inflated.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, based upon the damage observed, unintentional user error caused or contributed to this event.

• Brand Name: ET TUBE,CF,8.0
• 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: 17389306
• Report Number: 3003898360-2023-01164
• Device Sequence Number: 11731304
• Product Code: BTR
• UDI-Device Identifier: 14026704759153
• UDI-Public: 14026704759153
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

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 Expiration Date: 09/08/2026
• Device Catalogue Number: 5-10116
• Device Lot Number: 73J2100268
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2021
• 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
• Patient Sex: Unknown