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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. L-CATH; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

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ARGON MEDICAL DEVICES, INC. L-CATH; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Catalog Number 384540
Device Problem Fluid/Blood Leak (1250)
Patient Problem Venipuncture (2129)
Event Date 05/23/2018
Event Type  malfunction  
Event Description
A 28 gauge picc was placed in an infant without incident.An x-ray revealed that the picc was too deep and needed to be pulled back one cm.Once the picc was withdrawn it was noted that about 0.75 cm from the hub of the catheter there was a leak in the catheter.Catheter needed to be removed and a second picc placed.
 
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Brand Name
L-CATH
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
ARGON MEDICAL DEVICES, INC.
1445 flat creek road
athens TX 75751
MDR Report Key7609748
MDR Text Key111391636
Report Number7609748
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/24/2018
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 Nurse
Device Expiration Date02/01/2021
Device Catalogue Number384540
Device Lot Number11206411
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/24/2018
Device Age4 MO
Event Location Hospital
Date Report to Manufacturer05/24/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/18/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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