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U.S. Department of Health and Human Services

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

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MERIT MEDICAL SINGAPORE DTX SAFEDRAW KITS BLOOD PRESSURE MEASUREMENT SYSTEM. Back to Search Results
Catalog Number 682000/CNA
Device Problem Fluid 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.
 
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Brand NameDTX SAFEDRAW KITS
Type of DeviceBLOOD 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 Key12705614
MDR Text Key284368343
Report Number8020616-2021-00078
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K935782
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number682000/CNA
Device Lot NumberC2156093S1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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