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

Catalog Number 688639

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

The device is expected to return for evaluation.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 leaking at the planecta 3way stopcock.The set was replaced.No injury to report.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually.The complaint is confirmed.The root cause is attributed to overtightening during use.A review of the device history record and complaint database could not be performed since the lot number was not provided.

• 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: 8277435
• MDR Text Key: 134085743
• Report Number: 8020616-2019-00013
• 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: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2019
• 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: 01/30/2019
• Date Manufacturer Received: 04/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1