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U.S. Department of Health and Human Services

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

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ARGON MEDICAL DEVICE L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM Back to Search Results
Model Number 384539
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 10/12/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned. A follow-up report will be submitted once the device has been returned and evaluated.
 
Event Description
Withdraw of guidewire wire broke apart luckily all was retrieved.
 
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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 DEVICE
1445 flat creek rd
athens TX 75751
MDR Report Key12603035
MDR Text Key277113097
Report Number0001625425-2021-01091
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 11/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number384539
Device Catalogue Number384539
Device Lot Number11281534
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/13/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/10/2021 Patient Sequence Number: 1
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