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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 687987/JPA
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2019
Event Type  malfunction  
Manufacturer Narrative
The suspect device is not returning for evaluation.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.
 
Event Description
The account alleges that the tubing got disconnected from the upper portion of the drip chamber a new pressure monitoring kit was used for this patient.No injury to report.
 
Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents 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
76892 6
SN  768926
MDR Report Key9501118
MDR Text Key194784228
Report Number8020616-2019-00144
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 11/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2021
Device Catalogue Number687987/JPA
Device Lot NumberC1555256
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/28/2019
Initial Date FDA Received12/20/2019
Supplement Dates Manufacturer Received12/13/2019
Supplement Dates FDA Received01/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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