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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 688349
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/18/2020
Event Type  malfunction  
Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
Account alleges device began to leak blood during use.The account used tape to repair the device, then continued to use the device until the end of the procedure.No patient injury was reported.
 
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.Should the device be returned at a later date, the investigation will be re-opened.
 
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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
sn 76892 6
SN  768926
MDR Report Key10033638
MDR Text Key200456297
Report Number8020616-2020-00028
Device Sequence Number1
Product Code DSK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/21/2020
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 Catalogue Number688349
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2020
Initial Date Manufacturer Received 04/18/2020
Initial Date FDA Received05/07/2020
Supplement Dates Manufacturer Received07/02/2020
Supplement Dates FDA Received07/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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