MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC D/L 20GA (2.6F) 0.90MM X 60CM

Model Number 384466

Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Picc placed on 10 -26 / on 11-1 the cap started leaking during the night, after a tubing change.There was no injury, but the line was leaking all night so missed some of patient¿s total nutrition.The picc was replaced.

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.

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 found the luer was cracked and broken into two pieces at the cracked area.The crack in the luer 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.

Event Description

Picc placed 10 -26 / on 11-1 the cap started leaking during the night, after a tubing change.There was no injury, but the line was leaking all night so missed some of patient¿s total nutrition.The picc was replaced.

• Brand Name: L-CATH PICC D/L 20GA (2.6F) 0.90MM 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: 15914901
• MDR Text Key: 307903166
• Report Number: 0001625425-2022-01143
• Device Sequence Number: 1
• Product Code: LJS
• 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: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384466
• Device Catalogue Number: 384466
• Device Lot Number: 11427813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other