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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 686817/JPA
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2019
Event Type  malfunction  
Manufacturer Narrative
The device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that a black foreign object was identified within the fluid path of the pressure monitoring set.The pm set was not used for the procedure.The device was exchanged for a new set.No patient injury to report.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The device was examined visually.The complaint of fluid path contamination could not be confirmed.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 Key8353886
MDR Text Key136635571
Report Number8020616-2019-00019
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 01/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2023
Device Catalogue Number686817/JPA
Device Lot NumberC1356201
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2019
Date Manufacturer Received04/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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