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

Model Number	IPN048873
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A verification of the reported failure mode was conducted, and 200 samples were taken from the current production (00001-14 assembly,7.0 mm, sheridan cf murphy trach lot # 3009478) at the manufacturing facility.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.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 "the doctor found cuff leakage in the clinical setting before using on patient, no impact on the operation".No patient involvement reported.

• Brand Name: HUDSON ET TUBE,CF,7.5
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11545960
• Report Number: 3003898360-2021-00246
• Device Sequence Number: 19967774
• Product Code: BTR
• UDI-Device Identifier: 14026704616524
• UDI-Public: 14026704616524
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K822082
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2021

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 Expiration Date: 01/15/2024
• Device Model Number: IPN048873
• Device Catalogue Number: 5-10115
• Device Lot Number: 73A1900545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2021
• Initial Report FDA Received Date: 03/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1