• 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 PTE LTD. DTX SAFEDRAW PM KITS PRESSURE MONITORING SET

  • 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 PTE LTD. DTX SAFEDRAW PM KITS PRESSURE MONITORING SET Back to Search Results
Catalog Number 689549/JPA
Device Problems Fluid Leak (1250); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/10/2021
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 the aspiration syringe during prep due to cracking. The pm set was replaced. No patient injury to report.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameDTX SAFEDRAW PM KITS
Type of DevicePRESSURE MONITORING SET
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, 76892 6
SN 768926
Manufacturer (Section G)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, 76892 6
SN 768926
Manufacturer Contact
bryson heaton
1600 merit parkway
south jordan, UT 84095
MDR Report Key11890651
MDR Text Key255451529
Report Number8020616-2021-00030
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,Followup
Report Date 05/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number689549/JPA
Device Lot NumberC2026482
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/02/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-