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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 Problem Insufficient Information (4580)
Event Date 03/26/2023
Event Type  malfunction  
Manufacturer Narrative
Sample is not available for return.A follow-up report will be submitted after investigation completion.
 
Event Description
Rn went to check picc line at 0400, found it to be leaking in the bed.Rn called md to bedside to assess, picc line was cracked at the hub.Picc line removed by md.Charge nurse notified.Charge nurse obtained defective picc line.
 
Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.According to the per, there was no sample available for review.However, due to the number of complaints against this part number and lot number, this complaint will be 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
Rn went to check picc line at 0400, found it to be leaking in the bed.Rn called md to bedside to assess, picc line was cracked at the hub.Picc line removed by md.Charge nurse notified.Charge nurse obtained defective 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 Key16707187
MDR Text Key312962915
Report Number0001625425-2023-01019
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 Administrator/Supervisor
Type of Report Initial,Followup
Report Date 04/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2023
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 Number11440451
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/28/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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