MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE DTX SAFEDRAW KITS; BLOOD PRESSURE MEASUREMENT SYSTEM.

Catalog Number 689260

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2021

Event Type  malfunction  

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.Should the device be returned at a later date, the investigation will be re-opened.

Event Description

The account alleges that during the hemodynamic monitoring of a patient, the pressure monitoring [pm] set was found to be leaking fluid from the three way stop cock.No additional patient consequences to report.

• Brand Name: DTX SAFEDRAW KITS
• Type of Device: BLOOD PRESSURE MEASUREMENT SYSTEM.
• Manufacturer (Section D): MERIT MEDICAL SINGAPORE; 198 yishun ave 7; singapore, 76892 6; SN 768926
• MDR Report Key: 12705651
• MDR Text Key: 278616294
• Report Number: 8020616-2021-00076
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 04589731125191
• UDI-Public: 4589731125191
• Combination Product (y/n): N
• PMA/PMN Number: K935782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 689260
• Date Manufacturer Received: 10/15/2021
• 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