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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE; HUMIDIFIER NEBULIZER KIT
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TELEFLEX MEDICAL HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE; HUMIDIFIER NEBULIZER KIT Back to Search Results
Catalog Number 003-40F
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
Event Type  malfunction  
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 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.
 
Event Description
It was reported that: "during the use of aquapacks, the connector broke when the user screwed the connector to flowmeter".No patient harm or injury reported.Unknown patient condition at time of report.
 
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Brand Name
HUDSON AQUAPAK 340 SW,340 ML W/040 ADAPTOR,FRE
Type of Device
HUMIDIFIER NEBULIZER KIT
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key11641591
MDR Text Key244653529
Report Number1417411-2021-00008
Device Sequence Number1
Product Code OGG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number003-40F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/23/2021
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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