MAUDE Adverse Event Report: ANGIODYNAMICS, INC 28CM EVENMORE HEMODIALYSIS CATHETER SET; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number 10303502

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2019

Event Type  Injury  

Event Description

Patient had malfunctioning permcath placed at another acute care facility.Leaking from the tubing of blue port noted.Permath replace over wire.

• Brand Name: 28CM EVENMORE HEMODIALYSIS CATHETER SET
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS, INC
• MDR Report Key: 8331577
• MDR Text Key: 136011459
• Report Number: MW5083897
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10303502
• Device Lot Number: 5412497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR