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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SAMPLING SYSTEM

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MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SAMPLING SYSTEM Back to Search Results
Catalog Number 688626
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/18/2020
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 in preparations for the hemodynamic monitoring of a patient, the pressure monitoring [pm] set was found to be leaking just before the aspiration port. No patient interaction. A new device was used to complete the procedure.
 
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Brand NameSAFEDRAW BLOOD SAMPLING SYSTEM
Type of DeviceBLOOD SAMPLING SYSTEM
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
david lockridge
1600 meit parkway
south jordan, ut 
2531600
MDR Report Key10254309
MDR Text Key202254282
Report Number8020616-2020-00035
Device Sequence Number1
Product Code DXN
Combination Product (y/n)N
Reporter Country CodeSW
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 06/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number688626
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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