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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. ULTRASTREAM; CATHETER, HEMODIALYSIS, IMPLANTED
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ARGON MEDICAL DEVICES INC. ULTRASTREAM; CATHETER, HEMODIALYSIS, IMPLANTED Back to Search Results
Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 02/17/2018
Event Type  Injury  
Manufacturer Narrative
A review of the device history record could not be conducted as the device's catalog number and lot number are unknown.Additionally, the device was not returned for evaluation.There is no indication of permanent injury to the patient.If the device is returned in the future, a thorough evaluation will be conducted and a follow-up report will be submitted.
 
Event Description
Venous catheter lumen cross threaded with hd lines causing a blood leak of approx 500-600 ml of blood in 45 minutes.
 
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Brand Name
ULTRASTREAM
Type of Device
CATHETER, HEMODIALYSIS, IMPLANTED
Manufacturer (Section D)
ARGON MEDICAL DEVICES INC.
1445 flat creek road
athens TX 75751
Manufacturer (Section G)
ARGON MEDICAL DEVICES INC.
Manufacturer Contact
gail smith
1445 flat creek road
athens, TX 75751
2144368995
MDR Report Key7431520
MDR Text Key105510661
Report Number1625425-2018-00032
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/14/2018
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 N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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