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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEONATE DUAL HEATED DUAL DRAIN; HUMIDIFIER NEBULIZER KIT
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TELEFLEX MEDICAL HUDSON NEONATE DUAL HEATED DUAL DRAIN; HUMIDIFIER NEBULIZER KIT Back to Search Results
Model Number IPN913843
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/24/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be conducted since the lot number of the device was not provided.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 Description
It was reported "heated wire circuit did not pass the vent test prior to use on patient.During test, a leak could be heard (possibly a from a small hole in the circuit)".No patient involvement reported.
 
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Brand Name
HUDSON NEONATE DUAL HEATED DUAL DRAIN
Type of Device
HUMIDIFIER NEBULIZER KIT
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key12646837
MDR Text Key276854680
Report Number3004365956-2021-00286
Device Sequence Number1
Product Code OGG
UDI-Device Identifier14026704660510
UDI-Public14026704660510
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial
Report Date 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberIPN913843
Device Catalogue Number880-15KIT
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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