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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE SAFEDRAW BLOOD SAMPLING SYSTEM
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MERIT MEDICAL SINGAPORE SAFEDRAW BLOOD SAMPLING SYSTEM Back to Search Results
Model Number 682000
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/19/2020
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 during the hemodynamic monitoring of a patient in icu, the pressure monitoring [pm] set was found to be leaking between the rotating luer connection and the arterial needle.No patient injury to report.
 
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.The root cause could not be determined.  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
198 yishun ave 7
singapore, 76892 6
SN  768926
MDR Report Key10485820
MDR Text Key205469306
Report Number8020616-2020-00045
Device Sequence Number1
Product Code DSK
UDI-Device Identifier00886333620005
UDI-Public00886333620005
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 08/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number682000
Device Catalogue Number688410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2020
Date Manufacturer Received09/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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