MAUDE Adverse Event Report: VYGON USA VYGON; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 08/09/2022

Event Type  malfunction  

Event Description

Picc line was ordered to be removed.Adhesive remover was applied to help lift the tegaderm and steri-strips.Once loose, the catheter was noted to be completely separated at the hub.The loose end of the catheter was held and removed in its entirety; 17 cm removed.

• Brand Name: VYGON
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): VYGON USA; 2750 morris rd suite a200; lansdale PA 19446
• MDR Report Key: 16673419
• MDR Text Key: 312630889
• Report Number: 16673419
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/22/2023,09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12 DA
• Patient Sex: Female