MAUDE Adverse Event Report: VYGON USA NUTRILINE; INTRAVASCULAR CATHETER

Model Number 1252.030G

Device Problem Leak/Splash (1354)

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

Event Date 01/16/2024

Event Type  malfunction  

Manufacturer Narrative

This was reported directly to the fda - medwatch report number mw5150554 once the sample is received an investigation will be done and reported back to the fda within 30 days.

Event Description

2 fr vygon single lumen picc line inserted (b)(6) 2024.2nd dressing change done on (b)(6) 2024.Leaking noted after dressing change at proximal portion of catheter closest to "wings".Line then removed.

• 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: 18647854
• MDR Text Key: 335938458
• Report Number: 2245270-2024-00012
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2024
• 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: 23K004D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• 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
• Removal/Correction Number: MW5150554
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization