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

Model Number 384467

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 06/19/2023

Event Type  malfunction  

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 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
• 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 Key: 17306709
• MDR Text Key: 319444224
• Report Number: 0001625425-2023-01120
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00886333209866
• UDI-Public: 00886333209866
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other