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

Catalog Number 687603

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

Patient Problem Blood Loss (2597)

Event Date 08/05/2015

Event Type  malfunction  

Manufacturer Narrative

From the failure investigation and available information on the reported incident, the cause of complaint as described above could be the dimensional difference between coupling of the female and male luer fitting.Engineering evaluation have been carried out on the returned samples and compared with those on the stocks; the mold flow analysis conducted on the fitting and shown no stress point on the structure of the luer fitting.(see appendix a).Dimensional measurement was conducted on the inner surface of the female fitting and the male luer of the stopcock.Based on the dimensional analysis, the inner surface of the female luer 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 component particularly on female luer fitting.Production associates were informed on the complaint and not to over tighten during assembly.

Event Description

The product was used for approx 10 days.Blood leakage occurred at spc3 which was used for connection of syringe.Blood residue was observed at spc3.Strongly recommend to the customer about regular replacement of the monitoring kit.

• 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: 5537167
• MDR Text Key: 41822859
• Report Number: 8020616-2016-00021
• 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

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 687603
• Device Lot Number: 502253
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2015
• 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