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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 26GA (1.9F) 0.60MM X 30CM

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ARGON MEDICAL DEVICES INC. L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM Back to Search Results
Catalog Number 384539
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The complainant did not indicate if the sample device is available for evaluation. A follow-up report will be provide by 4/3/2020 in anticipation of a response to the requests for the return of the device.
 
Event Description
Please ship no charge replacement product to the following address: (b)(6). *strain relief slid out of the hub and down the indwelling portion of the picc. Picc cut below strain relief by nurse and repaired so the picc may continue to be utilized. *per (b)(6) -value analysis --- risk management will notify him if the product may or may not be returned to argon quality. If product is released by risk management, a document will need to be signed prior to release by argon.
 
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Brand NameL-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
Type of DeviceL-CATH PICC
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 Key9787978
MDR Text Key185009287
Report Number1625425-2020-00200
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/01/2005,02/19/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number384539
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received01/14/2005
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

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