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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 Problem Crack (1135)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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
¿less than 24 hours after insertion, the bedside nurse noted leakage.Upon assessment, the picc had a crack in the plastic part of the hub.We replaced it with another brand, but still have the broken one.¿.
 
Event Description
¿less than 24 hours after insertion, the bedside nurse noted leakage.Upon assessment, the picc had a crack in the plastic part of the hub.We replaced it with another brand, but still have the broken one.¿.
 
Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.After three notifications, there has been no sample returned for review.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the results are inconclusive and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, this complaint will be reopened for further evaluation at that time.
 
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Brand Name
L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
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 Key16454312
MDR Text Key310370512
Report Number0001625425-2023-00975
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00886333209934
UDI-Public00886333209934
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 Nurse
Type of Report Initial,Followup
Report Date 04/17/2023
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 Number384539
Device Catalogue Number384539
Device Lot Number11445820
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/13/2023
Initial Date FDA Received02/28/2023
Supplement Dates Manufacturer Received02/13/2023
Supplement Dates FDA Received04/17/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2022
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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