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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE DTX SAFEDRAW KITS.; BP-MONITORING SET
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MERIT MEDICAL SINGAPORE DTX SAFEDRAW KITS.; BP-MONITORING SET Back to Search Results
Catalog Number 689239
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/02/2022
Event Type  malfunction  
Event Description
The account alleges that during a hemodynamic pressure monitoring procedure, leakage occurred from a crack in the 3-way stopcock at the elbow of the syringe.No patient injury to report.
 
Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
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Brand Name
DTX SAFEDRAW KITS.
Type of Device
BP-MONITORING SET
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 bsn,rn.
1600 merit parkway
south jordan, UT 84095
MDR Report Key15380168
MDR Text Key299975602
Report Number8020616-2022-00066
Device Sequence Number1
Product Code DSK
UDI-Device Identifier04589731124408
UDI-Public4589731124408
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 09/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number689239
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/01/2022
Initial Date FDA Received09/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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