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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SUPPLY SYSTEM
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MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SUPPLY SYSTEM Back to Search Results
Catalog Number 682027/B
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/11/2019
Event Type  malfunction  
Manufacturer Narrative
The device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that during a hemodynamic monitoring procedure, the tubing near the septum was damaged.Blood was leaking from the tubing.The patients monitor reflected the tubing damage.The device was exchanged for a new one.No patient injury to report.
 
Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed and the 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.
 
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Brand Name
SAFEDRAW BLOOD SUPPLY SYSTEM
Type of Device
BLOOD SUPPLY SYSTEM
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
singapore, 76892 6
SN  768926
MDR Report Key8363841
MDR Text Key137006189
Report Number8020616-2019-00020
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 02/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2023
Device Catalogue Number682027/B
Device Lot NumberC1464091
Was Device Available for Evaluation? No
Date Manufacturer Received03/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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