MAUDE Adverse Event Report: VYGON USA 2FR PICC; CATHETER INTRAVASCULAR

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem Discomfort (2330)

Event Date 04/22/2023

Event Type  malfunction  

Event Description

Infant had a picc (peripherally inserted central catheter) line that had a lifting dressing.I was changing the dressing, and when i had it open and was cleaning it, i noticed it was leaking at the hub.I removed it and we got a new order and consent, so i placed a new picc line.Event reached patient - caused significant harm or required major intervention.

Manufacturer Narrative

Malfunction was first reported to fda via medwatch- (b)(4).Vygon's rep is reaching out to customer to get needed information, once received a follow up report will be submtted.

• Brand Name: 2FR PICC
• Type of Device: CATHETER INTRAVASCULAR
• 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: 18548238
• MDR Text Key: 333345739
• Report Number: 2245270-2024-00005
• 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: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/11/2024
• 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: 1000060000-2023-8028
• Patient Sequence Number: 1