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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX HUDSON VENTILATOR TUBING SET, LONG LENGHT; BREATHING CIRCUIT
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TELEFLEX HUDSON VENTILATOR TUBING SET, LONG LENGHT; BREATHING CIRCUIT Back to Search Results
Catalog Number 1613
Device Problems Leak/Splash (1354); Connection Problem (2900)
Patient Problem No Patient Involvement (2645)
Event Date 04/22/2014
Event Type  malfunction  
Event Description
The event is reported as: the customer alleges that he corrugated tubing pulled loose from the wye on the circuit.The customer reports that the circuit leaks.The alleged issue detected prior to pt use.
 
Manufacturer Narrative
The device sample was received by the mfr, but the investigation is incomplete at the time of this report.A device history record could not be conducted since the lot number was not provided; therefore it is not possible to determine in which conditions this material was manufactured.
 
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Brand Name
HUDSON VENTILATOR TUBING SET, LONG LENGHT
Type of Device
BREATHING CIRCUIT
Manufacturer (Section D)
TELEFLEX
nuevo laredo
MX 
Manufacturer (Section G)
TELEFLEX
ave. industrias no.5954
parque industrial finsa
nuevo laredo, tamaulipas
MX  
Manufacturer Contact
margie burton, rn
po box 12600
durham, NC 27709
9194334965
MDR Report Key3912380
MDR Text Key4514901
Report Number3004365956-2014-00184
Device Sequence Number1
Product Code CAG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 04/22/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1613
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/25/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received04/22/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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