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

Catalog Number 689069/B

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.

Event Description

The account alleges that during the hemodynamic monitoring of a patient, the pressure monitoring [pm] set was found detached at a connection.This resulted in a significant drop in the patient's arterial pressure on the monitor and appropriate resuscitation efforts were undertaken by the clinical staff.

• Brand Name: SAFEDRAW BLOOD SAMPLING SYSTEM
• Type of Device: BLOOD SAMPLING SYSTEM
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, 76892 6; SN 768926
• Manufacturer (Section G): MERIT MEDICAL SINGAPORE PTE LTD.; 198 yishun ave 7; singapore, 76892 6; SN 768926
• Manufacturer Contact: david lockridge ; 1600 merit parkway; south jordan, ut ; 2084551
• MDR Report Key: 9832140
• MDR Text Key: 189988982
• Report Number: 8020616-2020-00016
• Device Sequence Number: 1
• Product Code: DXN
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K935782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 689069/B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention