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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM
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ARGON MEDICAL DEVICES L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM Back to Search Results
Model Number 384466
Device Problems Crack (1135); Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2022
Event Type  malfunction  
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.
 
Event Description
¿6-month-old male with history of congenital heart disease.The patient¿s existing right lower extremity picc hub cracked and referred for placement.It was saved for investigation.This picc is the third with a lot number already identified as problematic.The remaining picc¿s with the lot number have been removed from inventory until the investigation is complete.¿ picture attached.
 
Event Description
¿6-month-old male with history of congenital heart disease.The patient¿s existing right lower extremity picc hub cracked and referred for placement.It was saved for investigation.This picc is the third with a lot number already identified as problematic.The remaining picc¿s with the lot number have been removed from inventory until the investigation is complete.¿ picture attached.
 
Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.One opened catheter was returned for review.Visual inspection confirmed a crack in the luer that would result in leakage.Several complaints for this part number have previously been received regarding a cracked hub resulting in leakage, and capa 2021-039 was initiated to address this issue.The capa is currently in the implementation phase and will evaluate the corrective action implementation for effectiveness to prevent a recurrence of this issue.
 
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Brand Name
L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM
Type of Device
L-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 Key16265176
MDR Text Key308736032
Report Number0001625425-2023-00947
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091670
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/13/2023
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 Health Professional
Device Model Number384466
Device Catalogue Number384466
Device Lot Number11447857
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/17/2023
Initial Date FDA Received01/30/2023
Supplement Dates Manufacturer Received01/17/2023
Supplement Dates FDA Received03/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/18/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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