MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SUPPLY SYSTEM

Catalog Number 688639

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

The suspect device has returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a pressure monitoring procedure, a leak was found between the planecta stop cock and the tubing that connects to the patient.The set was replaced.No patient injury to report.

Manufacturer Narrative

In preparation for submitting 3500a follow up information, it was discovered that this 3500a filing for was a duplicate of the 3500a [rga nc-109525 mdr # 8020616-2018-00090] that was filed on 12-20-2018.

• Brand Name: SAFEDRAW BLOOD SUPPLY SYSTEM
• Type of Device: BLOOD SUPPLY SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, 76892 6; SN 768926
• MDR Report Key: 8170883
• MDR Text Key: 130545582
• Report Number: 8020616-2018-00094
• Device Sequence Number: 1
• Product Code: DSK
• Combination Product (y/n): N
• PMA/PMN Number: K885235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/28/2018

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: Health Professional
• Device Catalogue Number: 688639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 12/24/2018
• Supplement Dates FDA Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1