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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 689610/JPB
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/03/2020
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, the pressure monitoring set was found to be leaking fluid.No patient injury to report.
 
Manufacturer Narrative
The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.The root cause is attributed to a crack on the component, it is likely that significant force was applied to the device during use.A search of the complaint database found one similar complaint for this lot number from the same customer.The device history record was reviewed and no exception documents were found.
 
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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 Key9920875
MDR Text Key198937855
Report Number8020616-2020-00022
Device Sequence Number1
Product Code DXN
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 03/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number689610/JPB
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2020
Date Manufacturer Received04/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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