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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 Crack (1135); Fluid/Blood Leak (1250)
Patient Problem Needle Stick/Puncture (2462)
Event Date 10/23/2022
Event Type  malfunction  
Event Description
The concern is: a baby had 2 picc lines in 3 days and both were leaking.The rn stated the issue was a crack in the plastic hub as well and taking out a stylet that was jagged and pulling at the line when she was trying to remove it.I believe the lot number is 11388769.Unfortunately, the staff did not save the packaging just the actually picc line.
 
Manufacturer Narrative
Sample is indicated as available for return.As of the date of this report, sample has not been returned.A follow-up report will be submitted once the sample has been received and reviewed.
 
Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.According to the customer, there was no sample available for this complaint.However, due to previous complaints regarding this issue with this lot number, this complaint is confirmed.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.
 
Event Description
The concern is: a baby had 2 picc lines in 3 days and both were leaking.The rn stated the issue was a crack in the plastic hub as well and taking out a stylet that was jagged and pulling at the line when she was trying to remove it.I believe the lot number is 11388769.Unfortunately, the staff did not save the packaging just the actually picc line.
 
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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 Key15741106
MDR Text Key307621833
Report Number0001625425-2022-01130
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 12/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/06/2022
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 Number11388769
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Other;
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