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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 687706/JPA
Device Problem Fluid/Blood Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 12/14/2018
Event Type  Injury  
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 during a hemodynamic pressure monitoring procedure within the newborn intensive care unit [nicu], blood was found leaking from the placenta on the pressure monitoring set.No patient injury was reported.
 
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 Key8190095
MDR Text Key131174239
Report Number8020616-2018-00091
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 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2020
Device Catalogue Number687706/JPA
Device Lot NumberC1356250
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/14/2018
Initial Date FDA Received12/21/2018
Supplement Dates Manufacturer Received02/25/2019
Supplement Dates FDA Received03/15/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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