MAUDE Adverse Event Report: VYGON USA NUTRILINE; INTRAVASCULAR CATHETER

Model Number 1252.030G

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 01/12/2024

Event Type  malfunction  

Event Description

Upon doing a picc (peripherally inserted central catheter) dressing change, the rn (registered nurse) noted leaking from where the device hub and catheter meet.The line was removed per md (medical doctors's) order.

Manufacturer Narrative

This malfunction was first reported to fda by the customer via medwatch (b)(4) the device has not yet been returned to vygon, but the complaint details have been sent to vygon gmbh for complaint investigation.The results of this investigation are still pending, and will be communicated to fda within 30 days of its conclusion.

• Brand Name: NUTRILINE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON USA; 2750 morris road; lansdale PA 19446
• Manufacturer (Section G): VYGON MFG; 87 venture drive; dover NH 03820
• Manufacturer Contact: wanda dumont ; 2750 morris road; lansdale, PA 19446 ; 8004735414
• MDR Report Key: 18734251
• MDR Text Key: 336764620
• Report Number: 2245270-2024-00020
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051690
• 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
• Report Date: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1252.030G
• Device Lot Number: 23I009D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: No
• 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 Age: 2 MO
• Patient Sex: Male
• Patient Weight: 2 KG
• Patient Ethnicity: Hispanic