MAUDE Adverse Event Report: ARGON MEDICAL DEVICE, INC. L-CATH PICC S/L; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Lot Number 11405477

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/24/2022

Event Type  Injury  

Event Description

When inserting a picc line the hub was noted to be cracked and a new line had to be placed.The second line placed was later found to be leaking around the smart site hub where it attaches to the line.The line again was switched.Event abated after use stopped.

• Brand Name: L-CATH PICC S/L
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): ARGON MEDICAL DEVICE, INC.
• MDR Report Key: 15147839
• MDR Text Key: 297151276
• Report Number: MW5111224
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/29/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 11405477
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 DA
• Patient Sex: Female
• Patient Weight: 1 KG
• Patient Race: Black Or African American