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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 689670/JPC
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/10/2020
Event Type  malfunction  
Manufacturer Narrative
The suspect device has been returned 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, air ingress from a 3-way stopcock was identified.No patient injury to report.
 
Manufacturer Narrative
The suspect device was returned for evaluation.A visual inspecting and functional testing was performed.The complaint was not confirmed.The root cause could not be determined as device performed to its intended function during testing.A review of the device history and complaint database could not be performed since the lot number was not provided.
 
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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 Key9679255
MDR Text Key195569272
Report Number8020616-2020-00009
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 01/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number689670/JPC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/18/2020
Date Manufacturer Received04/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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