MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM

Model Number 384539

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problems Pain (1994); Needle Stick/Puncture (2462)

Event Date 10/18/2022

Event Type  malfunction  

Event Description

Picc line that was inserted at the stollery was noted to be leaking out of a hole in the line.The line had been infusing well but at a slow iv rate thus not showing a leak.It needed to be adjusted today and when the physician flushed the line they noticed a small hole that was leaking.The line was removed.Impact of incident: the infant is at risk for infection due to the unknown amount of time that this hole was there.The infant also had to have a new picc line inserted which is another risk for infection, as well as this is a painful procedure that he had to endure.

Manufacturer Narrative

According to the customer, the sample was not available for review.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the results are inconclusive and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, this complaint will be reopened for further evaluation at that time.

• 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 Key: 15702630
• MDR Text Key: 307082694
• Report Number: 0001625425-2022-01121
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00886333209934
• UDI-Public: 00886333209934
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2024
• Device Model Number: 384539
• Device Catalogue Number: 384539
• Device Lot Number: 11347875
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other