MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC D/L 18GA (3.5F) 1.20MM X 60CM

Model Number	384467
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
¿blue lumen cracked leaking fluids, a new line had to be placed due to patient needs.¿ affect on patient-¿temporary harm, event occurred while in use with patient.¿.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
¿blue lumen cracked leaking fluids, a new line had to be placed due to patient needs.¿ affect on patient-¿temporary harm, event occurred while in use with patient.¿.
Event or Problem Description
¿blue lumen cracked leaking fluids, a new line had to be placed due to patient needs.¿ affect on patient-¿temporary harm, event occurred while in use with patient.¿.
Additional 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 of the blue lumen 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.

• Brand Name: L-CATH PICC D/L 18GA (3.5F) 1.20MM X 60CM
• Common Device Name: 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 Key: 14745081
• Report Number: 0001625425-2022-01033
• Device Sequence Number: 11350632
• Product Code: LJS
• UDI-Device Identifier: 00886333209866
• UDI-Public: 00886333209866
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2025
• Device Model Number: 384467
• Device Catalogue Number: 384467
• Device Lot Number: 11402259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2022
• Supplement Date Received by Manufacturer: 06/16/2022; 06/16/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 07/26/2022; 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown