• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE DTX SAFEDRAW PM KITS PRESSURE MONITORING SET, PRODUCT CODE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MERIT MEDICAL SINGAPORE DTX SAFEDRAW PM KITS PRESSURE MONITORING SET, PRODUCT CODE Back to Search Results
Catalog Number 689128
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2021
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 a crack under the male adaptor. No patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDTX SAFEDRAW PM KITS
Type of DevicePRESSURE MONITORING SET, PRODUCT CODE
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 Key11739351
MDR Text Key247770196
Report Number8020616-2021-00022
Device Sequence Number1
Product Code DXN
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 company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number689128
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

-
-