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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ET TUBE,CF,7.5; TUBE, TRACHEAL (W/WO CONNECTOR
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TELEFLEX MEDICAL HUDSON ET TUBE,CF,7.5; TUBE, TRACHEAL (W/WO CONNECTOR Back to Search Results
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 01/11/2021
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.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 that "doctor found the cuff leakage during function test prior to the patient".Device replaced.No patient involvement reported.
 
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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 Key11298235
Report Number3003898360-2021-00084
Device Sequence Number5036434
Product Code BTR
UDI-Device Identifier14026704616524
UDI-Public14026704616524
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K822082
Number of Events Summarized1
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) 01/18/2021
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 Date05/28/2024
Device Model NumberIPN048873
Device Catalogue Number5-10115
Device Lot Number73E1900786
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 01/18/2021
Initial Report FDA Received Date02/08/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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