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

Catalog Number 682051

Device Problem Improper Flow or Infusion (2954)

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

Event Date 11/29/2014

Event Type  malfunction  

Manufacturer Narrative

Visual observation on the returned sample showed that cracked was observed from the female luer fitting of the 50¿ clear pressure tubing assembly and female luer fitting of 3way red stopcock.The cavity number ¿38¿ was printed on the female luer fitting of red stopcock & cavity number ¿n16¿ was printed on the female luer fitting of 50¿ clear pressure tubing.The batch documents have been reviewed and the records showed that no problem was found relating to damage component or leakage during the manufacturing process.The review confirmed that all the operations, materials and tests were performed per manufacturing procedures.From the reported lot numbers, the affected kit assembly was manufactured in may 2014.Engineering evaluation 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.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.New stopcocks which have smaller dimension on the male luer have been implemented and will be fully cut over by july 2015.As part of the containment action, it is 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

The blood back flow to the transducer.

• 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: 5537007
• MDR Text Key: 41830172
• Report Number: 8020616-2016-00017
• Device Sequence Number: 1
• Product Code: DSK
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/30/2019
• Device Catalogue Number: 682051
• Device Lot Number: 405711
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2014
• Initial Date FDA Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1