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

Model Number	384467
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.
Event or Problem Description
Called to bedside by rn who reported fluids leaking from picc.Upon assessment, lipids leaking at microclave connection.Connection appeared loose, upon tightening, blood began to back up into lumen.Of note, cap change performed previous day on this red lumen and t-connector applied due to history of this type of picc lines cracking, however, t-connector had been applied with microclave attached to picc line.Microclave removed under sterile conditions and new t-connector applied.Crack confirmed, line clamped and fluids d/c'd from line.Flc notified, us guided piv placed.

• 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: 17306709
• Report Number: 0001625425-2023-01120
• Device Sequence Number: 20429051
• Product Code: LJS
• UDI-Device Identifier: 00886333209866
• UDI-Public: 00886333209866
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2025
• Device Model Number: 384467
• Device Catalogue Number: 384467
• Device Lot Number: 11418339
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown