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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW¿ SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

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MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW¿ SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE Back to Search Results
Model Number 682000
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/25/2022
Event Type  malfunction  
Manufacturer Narrative
The suspect device is expected to return for evaluation. A follow up will be submitted when the evaluation is complete.
 
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 3-way stopcock. No patient injury to report.
 
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Brand NameSAFEDRAW¿
Type of DeviceSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, sgp 76892 6
SN 768926
Manufacturer (Section G)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, sgp 76892 6
SN 768926
Manufacturer Contact
bryson heaton
1600 merit parkway
south jordan, UT 84095
8012084662
MDR Report Key14861645
MDR Text Key299976478
Report Number8020616-2022-00042
Device Sequence Number1
Product Code DXN
UDI-Device Identifier00886333620005
UDI-Public00886333620005
Combination Product (y/n)N
Reporter Country CodeJA
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 06/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number682000
Device Catalogue Number689746/JPB
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received07/12/2022
Was Device Evaluated by Manufacturer? Yes
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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