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

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.

• 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 Key: 6529080
• MDR Text Key: 73898749
• Report Number: 8020616-2017-00001
• Device Sequence Number: 1
• Product Code: DSK
• Combination Product (y/n): N
• PMA/PMN Number: K885235
• Number of Events Reported: 1
• 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 Number: SCK-1660
• Device Catalogue Number: 688844
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2017
• Initial Date FDA Received: 04/28/2017
• 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 Number: 1
• Patient Outcome(s): Required Intervention