Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 BLOOD PRESSURE KIT; 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 BLOOD PRESSURE KIT; PRESSURE MONITORING SET Back to Search Results
Catalog Number 096002-000-591
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2021
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 at the blood sampling septum.No patient injury to report.
 
Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
DTX SAFEDRAW BLOOD PRESSURE KIT
Type of Device
PRESSURE MONITORING SET
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, 76892 6
SN  768926
MDR Report Key11637334
MDR Text Key246773195
Report Number8020616-2021-00019
Device Sequence Number1
Product Code DXN
UDI-Device Identifier00884450360873
UDI-Public884450360873
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/15/2021
Device Catalogue Number096002-000-591
Device Lot NumberC1888777
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2021
Date Manufacturer Received04/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-