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

Catalog Number 688077

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/04/2014

Event Type  malfunction  

Manufacturer Narrative

A failure analysis was conducted by argon critical care systems singapore pte.Ltd.To identify the cause of the reported failure.Evaluation methods employed included visual and functional inspection of the returned device, documentation and internal manufacturing process review and complaint trend analysis.The returned complaint sample showed that the connection between the safedraw and the 4¿ tubing assembly was found detached upon receipt.From the failure investigation and available information on the reported incident, the cause of the complaint described above is due to insufficient uv adhesive applied on the pressure tubing assembly.A review of the batch documentation, which included device history records and inspection reports, showed that there were no defects found during the assembly process.The pressure tubing assembly is bonded manually by applying uv adhesive onto the tubing and inserting it to the safedraw fitting.Visual inspection was conducted to check for any void between the bonded area and any detached tubing from fitting during assembly process.Pull test inspection results showed that the detachment force between the fitting and the tubing met the specification.Production associates were made aware on the defect on the received complaint and to give emphasis on the fillet that must be smooth and continuous and 100% visual inspection on the connection between the safedraw fitting after the bonding process.

Event Description

The line from the blood sampling port to the baby came apart/broken.It was noticed immediately and fortunately no harm done but had it not been noticed, it could have been catastrophic.

• 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: 5537008
• MDR Text Key: 41884832
• Report Number: 8020616-2016-00015
• Device Sequence Number: 1
• Product Code: DSK
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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 a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 688077
• Device Lot Number: 312225
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2014
• Initial Date FDA Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2013
• 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