MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE,HVT,7.5,NOVA PLUS; TUBE, TRACHEAL (W/WO CONNECTOR

Model Number	IPN048896
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Complaint from maude database: it was reported "patient was intubated with the et tube, but as the tube balloon was being inflated, it did not give the proper seal needed to help the patient.Extubation was needed to be done, and patient was re-intubated".No patient harm or injury reported.Patient condition not reported.
Additional Manufacturer Narrative
(b)(4).Mdr report key/report number (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Part number reported is not being manufactured currently, however, another part number from the same family was used for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 150 samples were taken from the current production; the samples were visually inspected, and issue reported "cuff did not seal trachea properly" was not observed in the current manufacturing process.A device history record review could not be conducted since the lot number reported was not a valid number.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.
Event or Problem Description
Complaint from maude database: it was reported "patient was intubated with the et tube, but as the tube balloon was being inflated, it did not give the proper seal needed to help the patient.Extubation was needed to be done, and patient was re-intubated".No patient harm or injury reported.Patient condition not reported.
Additional Manufacturer Narrative
Qn#(b)(4).Corrected data: section b.3.-date of event corrected to 03/13/2017.Section d.1.-brand name corrected to hudson et tube,hvt,7.5,nova plus.Section d.4.-catalog# corrected to v5-10315.Section d.4.-udi# corrected to (b)(4).Section e.4.-corrected to 'yes'.

• Brand Name: HUDSON ET TUBE,HVT,7.5,NOVA PLUS
• 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: 14190252
• Report Number: 3003898360-2022-00123
• Device Sequence Number: 17255030
• Product Code: BTR
• UDI-Device Identifier: 04026704588787
• UDI-Public: 04026704588787
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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 Model Number: IPN048896
• Device Catalogue Number: V5-10315
• Device Lot Number: 73B1500619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2022
• Supplement Date Received by Manufacturer: 06/21/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown