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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. L-CATH PICC S/L 28GA

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ARGON MEDICAL DEVICES, INC. L-CATH PICC S/L 28GA Back to Search Results
Catalog Number 384516
Device Problem Occlusion Within Device (1423)
Patient Problem Venipuncture (2129)
Event Date 01/22/2016
Event Type  malfunction  
Manufacturer Narrative
No lot number was provided in relation to this complaint; therefore, the device history record could not be reviewed. According to the complaint form, no product is available for return to argon quality in connection with this complaint. Without the return of the product, and with no lot number to review, a definitive cause for the occlusion of the catheter could not be determined. Catheter occlusion can be related to kinks or bends in the catheter under the dressing, conditions in the patient's body, drug and mineral precipitation in the catheter, or the development of thrombus. L-cath catheters are 100% visually inspected at various points in the manufacturing process and 100% leak and flow tested. Control catheters are also tested for tensile strength.
 
Event Description
Pt had picc placed over the weekend (refer to problem/event date) which could have been (b)(6) 2016. Picc line clotted sometime during the weekend. Clotted picc removed. A second picc had to be placed in this patient. Lot# unavailable/no product available for return.
 
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Brand NameL-CATH PICC S/L 28GA
Type of DeviceL-CATH
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 Key5448389
MDR Text Key39043910
Report Number1625425-2015-00082
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K020834
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 02/18/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number384516
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/26/2016
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

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