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

Model Number	IPN048897
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	02/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual inspection of the product involved in the complaint could not be conducted since the product was not returned.The part number reported is not being manufactured currently, however, another part number from the same family was use for the verification of failure mode reported in the current manufacturing process and was conducted and issue reported leak-device leak-cuff was not observed in the current manufacturing process.The device history review could not be conducted since the lot number was not provided.Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect.The customer complaint cannot be confirmed since the product sample is not available to perform a proper investigation and determine the root cause.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
Event or Problem Description
Reported issue: the cuff deflated and the patient had to be extubated and then reintubated.No injury reported.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one unit 5-10316 et tube, hvt, 8.0 for investigation.The returned et tube was visually examined with and with out magnification.Visual examination of the returned et tube revealed that the sample appears typical.A functional inspection was performed to attempt to inflate and deflate the balloon cuff on the returned et tube.No leaks were detected.Both the pilot balloon and balloon cuff were able to deflate.No functional issues were found with the returned sample.The device history review could not be conducted since the lot number was not provided and a potential lot number could not be found by looking at the sales history.A corrective action is not required at this time as the complaint could not be confirmed.The returned et tube was able to inflate and deflate with no difficulty.All et tubes are 100% inspected for inflation and deflation during manufacturing.All et tubes are inflated for 4 hours and then deflated to confirm proper assembly.The reported complaint of leak - device leak - cuff could not be confirmed based upon the sample received.The returned et tube was able to inflate and deflate with no difficulty.No functional issues were found with the returned device.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
Reported issue: the cuff deflated and the patient had to be extubated and then reintubated.No injury reported.

• Brand Name: ET TUBE, HVT, 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 16539823
• Report Number: 3003898360-2023-00304
• Device Sequence Number: 6193989
• Product Code: BTR
• UDI-Device Identifier: 14026704616760
• UDI-Public: 14026704616760
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2023

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 Model Number: IPN048897
• Device Catalogue Number: 5-10316
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 03/31/2023
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown