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. SAFEDRAW BLOOD SAMPLING SYSTEM
  • 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. SAFEDRAW BLOOD SAMPLING SYSTEM Back to Search Results
Catalog Number 689226
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2019
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 while prepping for a hemodynamic monitoring procedure, the pressure monitoring set was found to be leaking fluid at the stopcock connection.The pm set was exchanged for a new set and the monitoring successfully completed with no additional consequences to the patient.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually and functional testing was performed.The complaint could not be confirmed and a root cause could not be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were found.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SAFEDRAW BLOOD SAMPLING SYSTEM
Type of Device
BLOOD SAMPLING SYSTEM
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, 76892 6
SN  768926
MDR Report Key8761009
MDR Text Key156659885
Report Number8020616-2019-00060
Device Sequence Number1
Product Code DSK
Combination Product (y/n)N
PMA/PMN Number
K885235
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number689226
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2019
Date Manufacturer Received07/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-