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

Model Number	IPN048896
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Part # 5-10315 reported is not being manufactured currently, however, another part number from the same family (part # 0000-3-13 lot # 3136393) was used for the "verification of failure mode reported in the current manufacturing process" and was conducted as follows: 200 samples were taken from the current production; the samples were visually inspected and issue reported "leak - device leak - 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.
Event or Problem Description
It was reported "the nurse just heard air coming from patient, rt assessed, notified the provider, tube was exchanged out due to cuff leak".No patient harm or injury reported.Patient condition reported as "fine".

• Brand Name: HUDSON ET TUBE, HVT, 7.5
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• MDR Report Key: 12712358
• Report Number: 3003898360-2021-00984
• Device Sequence Number: 4704088
• Product Code: BTR
• UDI-Device Identifier: 14026704616753
• UDI-Public: 14026704616753
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2021

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: IPN048896
• Device Catalogue Number: 5-10315
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 10/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: VENTILATOR