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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  
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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
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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