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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE LTD DTX PRESSURE MONITORING KIT

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ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE LTD DTX PRESSURE MONITORING KIT Back to Search Results
Catalog Number 689111
Device Problems Fluid Leak (1250); Connection Problem (2900); Device Operates Differently Than Expected (2913)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 02/14/2016
Event Type  No Answer Provided  
Event Description
Connection failure between insyte and tube(hakko). Blood leakage occurred due to loose connection.
 
Manufacturer Narrative
Visual observation conducted on the returned samples and found that the insyte connected to the pt12r tubing is loosely joint with the component. A review of the batch documentation, which includes device history records and inspection reports, showed that no problem was found relating to leakage or damage connection on the reported lot number during manufacturing process. Based upon record review we can confirm that all of the operations, materials and testing were properly performed on the device from the reported lots and the test results show no failures or indications of a potential problem relating to the leakage. The lot number was manufactured in 30 october 2015. Analysis and evaluations have been carried out to confirm and determine the root cause on the reported leakage in between the insyte and tube (hakko). The returned device was pressurized with saline at 300mmhg, no fluid leakage was found during the test on this connection. With this, the cause of leakages complaint between insyte and tube (hakko) connection could not be determined due to no product functionality defect found. Potential cause of the said leakage may due to loose connection between insyte and the tubing during the product setup and/or usage in the operation.
 
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Brand NameDTX
Type of DevicePRESSURE MONITORING KIT
Manufacturer (Section D)
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE LTD
198 yishun avenue 7
76892 6
SN 768926
Manufacturer (Section G)
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE LTD
Manufacturer Contact
sylvia er
198 yishun avenue 7
MDR Report Key5503386
MDR Text Key40537222
Report Number8020616-2016-00013
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K935782
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other Health Care Professional
Device Expiration Date09/30/2020
Device Catalogue Number689111
Device Lot Number510687
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/30/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/16/2016 Patient Sequence Number: 1
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