MAUDE Adverse Event Report: ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE LTD SAFEDRAW; SAFEDRAW SET

Catalog Number 689124

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2015

Event Type  malfunction  

Manufacturer Narrative

Visual examination on the returned complaint device showed that there were stress marks or crease lines observed on the stopcock housing.Lever found with lifting from the housing core of the stopcock.The batch documents have been reviewed and the records showed that no defect was found relating to damage or leakage during manufacturing process.The reviewed confirmed that all the operations, materials and tests were performed per manufacturing procedures.From the reported lot numbers, the affected kit assembly lot number was manufactured in jun 2015.In the analysis of the returned sample was pressurized with saline at 300mmhg for 24 hours, leakage was found at the bottom and top of the stopcock housing.By checking all the ports and connection, the bonding found intact without damage or disruption in each component.Physical part shows craze line but no cracked housing was observed on the stopcock.Further detail analysis and evaluations were carried out on the structure and design of the stopcock, including manipulations on the lever.The evaluation results had the similar observations above.However based on evaluation, verification, discussion and conclusion on the returned product, the cause of complaint described could not be determined; the analysis has provided the possible causes.These are: the design of the stopcock is not robust to withstand certain handlings during product application.These handlings include the possibility of lifting the stopcock lever while turning the lever during usage.The combine effect of these 2 factors has an impact to the sealing area of the stopcock.A gap is possible created in this area when the lever is lifted and thus potentially result to leakage when the plunger is pulled rapidly during aspiration.The craze line or material stress found in the stopcock is a sign that the stopcock housing subject to a force by pulling or pushing creating a gap between the lever and the stopcock housing.The gap created may potentially result leakages as syringe is pulled fast during aspiration while holding the housing of the stopcock.The above information shall take precaution during product setup.It is recommended not to pull the lever of the stopcock with force since it may potentially create a gap on the housing and lever while in used.The following actions are being taken to address this complaint and the investigation findings: the stopcock supplier has been informed and engaged to review and make necessary design change in the stopcock to improve its robustness.During this interim period, replace the stopcocks in the current kits configuration to stopcocks without the 45 degree click feature.It is also recommend to the user not to pull the lever while turning the stopcock on a certain degree position during product used, it may potentially create a gap on the housing and lever wall profile.

Event Description

Fluid leakage occurred to the elcam stopcock which is connected to straight type of syringe.Leakage is from between cock lever and housing.The customer aspirated blood using the syringe.After that the leakage stopped because blood at leak part was dried and coagulated.Immediate investigation is necessary because the event occurred to the newly introduced elcam stopcock because those will be widely distributed in market in future.

• Brand Name: SAFEDRAW
• Type of Device: SAFEDRAW SET
• 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 Key: 5537276
• MDR Text Key: 41875771
• Report Number: 8020616-2016-00023
• Device Sequence Number: 1
• Product Code: DSK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K885235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 689124
• Device Lot Number: 506770
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2015
• 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