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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SCORPIONX PORTAL VEIN ACCESS SET SCORPION PORTAL VEIN ACCESS SET

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ARGON MEDICAL DEVICES SCORPIONX PORTAL VEIN ACCESS SET SCORPION PORTAL VEIN ACCESS SET Back to Search Results
Model Number TPS006
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 08/03/2022
Event Type  malfunction  
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Brand NameSCORPIONX PORTAL VEIN ACCESS SET
Type of DeviceSCORPION PORTAL VEIN ACCESS SET
Manufacturer (Section D)
ARGON MEDICAL DEVICES
1445 flat creek rd
athens TX 75751
Manufacturer Contact
elnaz rahman
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key15266753
Report Number0001625425-2022-01077
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00886333225729
UDI-Public00886333225729
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K213002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberTPS006
Device Catalogue NumberTPS006
Device Lot Number11388809
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received08/03/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/22/2022 Patient Sequence Number: 1
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