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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM

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ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM Back to Search Results
Model Number 384539
Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Patient Problem Insufficient Information (4580)
Event Date 02/08/2022
Event Type  malfunction  
Event Description
There was leakage from the catheter and the slightly larger part normally fixed on the catheter is removable on it, it slides along the fine catheter. There is also a loss of integrity at the level of the rigid plastic tip which screws(hub), it crumbles. The baby has not received all of the prescribed parenteral nutrition. Increased risk of infection since it is an entry route for microorganisms. Removing the catheter must undergo a new procedure and the associated pain. See the photo below:.
 
Manufacturer Narrative
The sample is indicated as available for return. As of the date of this report, the sample has not been returned. A follow-up report will be provided once the device has been received and reviewed.
 
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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
1445 flat creek rd
athens TX 75751
Manufacturer Contact
elnaz rahman
1445 flat creek rd
athens, TX 75751
9036759321
MDR Report Key13569730
MDR Text Key288684441
Report Number0001625425-2022-00952
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00886333209934
UDI-Public00886333209934
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 02/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number384539
Device Catalogue Number384539
Device Lot Number11388769
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/16/2022
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: 02/21/2022 Patient Sequence Number: 1
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