MAUDE Adverse Event Report: VYGON USA PREMICATH 1FR; INTRAVASCULAR CATHETER

Model Number 1261.203A

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Discomfort (2330)

Event Date 12/11/2023

Event Type  malfunction  

Event Description

Picc line broke near the insertion site and was leaking.

Manufacturer Narrative

The failed sample will be returned to vygon and will be evaluated as part of the complaint investigation.The results of this investigation are still pending and will be communicated with fda within 30 days of completion.

• Brand Name: PREMICATH 1FR
• 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: 18616141
• MDR Text Key: 334224726
• Report Number: 2245270-2024-00008
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K041468
• 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: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1261.203A
• Device Lot Number: 23A005D
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• 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: 33 DA
• Patient Sex: Male
• Patient Weight: 1 KG