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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SAMPLING SYSTEM
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MERIT MEDICAL SINGAPORE PTE LTD. SAFEDRAW BLOOD SAMPLING SYSTEM Back to Search Results
Catalog Number 682142/A
Device Problem Incomplete or Inadequate Connection (4037)
Patient Problem Blood Loss (2597)
Event Date 04/26/2019
Event Type  malfunction  
Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed and a root cause could not be determined.A review of the device history record and complaint database could not be performed since a lot number was not provided.
 
Event Description
The account alleges the blood would back up the tube and leak out of the connection near the red stopcock.When the nurse attempted to tighten the connection it would spin and not get tight.No injury was reported.
 
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Brand Name
SAFEDRAW BLOOD SAMPLING SYSTEM
Type of Device
BLOOD SAMPLING SYSTEM
Manufacturer (Section D)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
76892 6
SN  768926
Manufacturer (Section G)
MERIT MEDICAL SINGAPORE PTE LTD.
198 yishun ave 7
76892 6
SN   768926
Manufacturer Contact
katie swenson, cqe, cba, cqpa
1600 w merit parkway
south jordan 84095
8012081600
MDR Report Key8632735
MDR Text Key145837620
Report Number8020616-2019-00036
Device Sequence Number1
Product Code DSK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K885235
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other
Type of Report Initial
Report Date 04/29/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number682142/A
Was Device Available for Evaluation? No
Date Manufacturer Received04/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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