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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 682027
Device Problem Fluid/Blood Leak (1250)
Patient Problem Blood Loss (2597)
Event Date 04/29/2019
Event Type  malfunction  
Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that blood backed up the tube and the set leaked blood.The device was replaced with no injury to the patient.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The device was visually inspected and functional testing was performed.The complaint is confirmed.The tubing was found detached from the luer and the luer was found to be cracked.The root causes are suspected to be due to overtightening of the connection during the procedure and the manufacturing process.A review of the device history record and complaint database could not be performed since a lot number was not provided.
 
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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
MDR Report Key8640174
MDR Text Key146073704
Report Number8020616-2019-00044
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 05/02/2019
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 Catalogue Number682027
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2019
Initial Date Manufacturer Received 05/02/2019
Initial Date FDA Received05/24/2019
Supplement Dates Manufacturer Received06/07/2019
Supplement Dates FDA Received06/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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