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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON CRITICAL CARE SYSTEMS PTE. LTD. ARGON; PRESSURE MONITORING KIT

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ARGON CRITICAL CARE SYSTEMS PTE. LTD. ARGON; PRESSURE MONITORING KIT Back to Search Results
Model Number SCK-1660
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/29/2017
Event Type  Injury  
Manufacturer Narrative
Physical material review: visual examination was conducted on the returned complaint sample and showed that cracked on the female luer fitting of the red stopcock was observed upon receipt.The female luer fitting was connected to a male luer fitting of a non-argon tubing assembly device history record review: lot number was not provided for review however manufacturing process were reviewed and showed that no defect found and no indication of similar issue occurred during the manufacturing process.The review confirmed that all the operations, materials and tests were performed per manufacturing procedures.Kit¿s assembly goes through sampling outgoing inspection to check for any damaged or visual non-conformities that could affect the product functionality.Based on the above verification, analysis conducted on the sample review of the kits configuration and information provided in the per, it is concluded that the cause of the incident is due to the crack on the female luer fitting of the red stopcock.As per the kits configuration, the female luer fitting of the red stopcock was not connected to any devices, the cause occurred was likely due to mechanical stress incurred when tightening the connection with too much torque during product application.The crack propagated toward the housing from the tip of the female luer fitting of the stopcock.In the per, it mentioned that the products have been used for a week before the incident occurred, this indicated that the defect was likely contributed by the mechanical torque applied during product application.As the failure attributed outside the manufacturing process, no action will be taken.However, the production operators are made aware of the incidents and they were reminded not to over tighten the connections during assembly.Also, it is recommended to the user not to over tighten the connection during product used.This is to prevent unintended mechanical stress acting on the component which could cause crack on the device.
 
Event Description
Blood leak to an infant at nicu due to crack on the connection between syringe stopcock and tubing.Blood infusion was required because of unstable condition of the patient.The patient condition became stable after the treatment.The hospital does not intend to report this incident to regulatory authority because the pressure monitoring kit was kept using about 1 week.
 
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Brand Name
ARGON
Type of Device
PRESSURE MONITORING KIT
Manufacturer (Section D)
ARGON CRITICAL CARE SYSTEMS PTE. LTD.
198 yishun avenue 7
76892 6
SN  768926
Manufacturer (Section G)
ARGON CRITICAL CARE SYSTEMS PTE. LTD.
Manufacturer Contact
sylvia er
198 yishun avenue 7
MDR Report Key6529080
MDR Text Key73898749
Report Number8020616-2017-00001
Device Sequence Number1
Product Code DSK
Combination Product (y/n)N
PMA/PMN Number
K885235
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberSCK-1660
Device Catalogue Number688844
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/03/2017
Initial Date FDA Received04/28/2017
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
Patient Outcome(s) Required Intervention;
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