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

Catalog Number 688639

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/05/2015

Event Type  malfunction  

Manufacturer Narrative

Visual observation on the returned samples showed that crack was observed on the female luer fitting of 12¿ clear pressure tubing assembly.Cavity number ¿39¿ printed on the female luer fitting of 12¿ clear pressure tubing.Lot number was not available for batch documentation review.However, reviewed on the manufacturing process showed that no defect found relating to damage assembly and/or leakage during the manufacturing process.The review confirmed that all the operations, materials and tests were performed per manufacturing procedures.There is no indication of similar issue occurred during the manufacturing process.Engineering evaluation and external laboratory test have been carried out on the returned samples and compared with those on the stock.The mold flow analysis conducted on the fitting and shown no stress point on the structure of the luer fitting.Dimensional measurement was conducted on the inner surface of the female fitting and the male luer of the stopcock.Based on the dimension analysis, the inner surface of the female fitting is between nominal to lower (i.E.Can be smaller in size).The male luer has a dimension that is nominal to high (i.E.It is bigger in size).Hence when these 2 parts are coupled together, the interference fitting between the parts can be extremely tight to no tolerance, thus, further tightening of the parts can result to crack on the female fitting.An external laboratory test has been conducted to identify the failure, based on the analysis gathered on female luer fitting cracked the cause of failure came from creep fracture which is associated with alternating stress activity on the part and signs of periodic progress of the crack in the fractured surface will be observed.Analysis showed no trace of material degradation for all the samples analyzed.Crack was found to be initiated from the center of the luer fitting and propagated to the luer thread opening.Based on the evaluation, simulation, and conclusion the cause of the failure is attributed to material mechanical stress associated with the coupling of luer fitting resulted to crack.It is recommended to read section a of the ¿instruction for use¿ for set up procedure to avoid any cracked that may happen in the component during set up.The following actions are being taken to address this complaint and the investigation findings: production associates have been informed on the complaint and not to over tighten during assembly.Establish standard coupling method to eliminate material stress on the component.New stopcocks with male luer that has better fitting have been implemented since (b)(6) 2015.Manufacturing have done improvement in auto-machine by reducing the gripper arm speed to minimize the impact on the surface of female luer fitting which potentially cause of material stress in the component during product assembly.Manufacturing have done improvement in auto machine by reducing the gripper arm speed to minimize the impact on the surface of the female luer fitting.A shrink tube installed on flipper gripper as to reduce the impact of hitting the luer during grip.New stopcocks which have smaller dimension on the male luer have been implemented and will be fully cut over by (b)(6) 2015.It is also recommended that the connections to be uv bonded.This will prevent any further tightening during product application and hence reduce any potential crack on the female luer fitting.

Event Description

Puddle of blood on the floor was found during operation.Leakage from a-line was confirmed but the location is unknown.

• 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: 5537399
• MDR Text Key: 41887203
• Report Number: 8020616-2016-00024
• 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 Catalogue Number: 688639
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2015
• Initial Date FDA Received: 03/31/2016
• 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