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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 Device Reprocessing Problem (1091); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/15/2016
Event Type  No Answer Provided  
Event Description
Leakage from zeroing stopcock during use. The cock lever was at off (90 degree) position. It was confirmed that blood residue on the bottom the stopcock lever. The hospital reported that they haven't done unusual handling causes blood goes to zeroing stopcock.
 
Manufacturer Narrative
Visual examination of the returned sample found that the zeroing stopcock lever located at non-detent position. No damage component found on the returned kits. The batch documents have been reviewed and the records showed that no problem was found relating to any visual defects during the manufacturing process. The review confirmed that all the operations, materials and tests were performed per manufacturing procedures. Based on the analysis and evaluation, the cause of leakage described above is likely due to the lever was not in the exact ¿off¿ position. This resulted a gap between the stopcock body and the lever. The seal between the two parts hence become not effective and caused leakage.
 
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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 Key5503389
MDR Text Key40794482
Report Number8020616-2016-00014
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
Device Expiration Date09/30/2020
Device Catalogue Number689111
Device Lot Number510687
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
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 Treatment Data
Date Received: 03/16/2016 Patient Sequence Number: 1
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