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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RUSCH ET TUBE,CF,7.0; TUBE, TRACHEAL (W/WO CONNECTOR
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RUSCH ET TUBE,CF,7.0; TUBE, TRACHEAL (W/WO CONNECTOR Back to Search Results
Model Number IPN048872
Medical Device Problem Code Gas/Air Leak (2946)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/01/2021
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 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: "the cuff deflated when patients were positioned in prone position.No patient injury or harm reported.Patient condition reported as "fine".
 
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Brand Name
RUSCH ET TUBE,CF,7.0
Common Device Name
TUBE, TRACHEAL (W/WO CONNECTOR
MDR Report Key12638964
Report Number3003898360-2021-00956
Device Sequence Number6107681
Product Code BTR
UDI-Device Identifier14026704616517
UDI-Public14026704616517
Combination Product (Y/N)N
Initial Reporter CountryFR
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) 09/24/2021
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 No Information
Device Expiration Date12/15/2025
Device Model NumberIPN048872
Device Catalogue Number5-10114
Device Lot Number73M2000514
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/24/2021
Initial Report FDA Received Date10/15/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured12/16/2020
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 Number1
Concomitant Medical Products
and Therapy/Usage Dates
N/A.
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