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

Catalog Number 682000/CNA

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/02/2021

Event Type  malfunction  

Event Description

The account alleges that during the hemodynamic monitoring of a patient, the dtx pressure monitoring [pm] set was found to be leaking air and blood at the pressure sensor adapter of the device.The pm set was exchanged, and the procedure was successfully completed.No additional patient consequences to report.No additional patient consequences to report.

Manufacturer Narrative

The suspect device will not be returning for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• 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
• Manufacturer (Section G): MERIT MEDICAL SINGAPORE; 198 yishun ave 7; singapore, 76892 6; SN 768926
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 12705614
• MDR Text Key: 284368343
• Report Number: 8020616-2021-00078
• Device Sequence Number: 1
• Product Code: DXN
• UDI-Device Identifier: 04589731125191
• UDI-Public: 4589731125191
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K935782
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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: 682000/CNA
• Device Lot Number: C2156093S1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2021
• 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 Age: 73 YR
• Patient Sex: Female