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

Catalog Number 686304/B

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 05/28/2019

Event Type  malfunction  

Manufacturer Narrative

The device is not expected to return.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during the hemodynamic monitoring of a patient, the pressure monitoring set was found to be detached and leaking blood and saline.The pm set was exchanged for a new one and the monitoring procedure was successfully completed with no additional consequences to the patient.

Manufacturer Narrative

Twenty-five unused units from the same lot were returned for evaluation.The devices were examined visually and functional testing was performed.The complaint could not be confirmed and a root cause could not be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and one similar complaint for this lot number was found.

• 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: 8807483
• MDR Text Key: 151601966
• Report Number: 8020616-2019-00065
• 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: 06/28/2019

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 Expiration Date: 08/31/2023
• Device Catalogue Number: 686304/B
• Device Lot Number: C1402686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Manufacturer Received: 06/28/2019
• Initial Date FDA Received: 07/19/2019
• Supplement Dates Manufacturer Received: 08/15/2019
• Supplement Dates FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1