MAUDE Adverse Event Report: ANGIODYNAMICS SCHON XL DOUBLE LUMEN CATHETER; HEMODIALYSIS CATHETER

Catalog Number 10802703

Device Problems Fluid/Blood Leak (1250); Material Fragmentation (1261)

Patient Problem Blood Loss (2597)

Event Date 05/16/2017

Event Type  malfunction  

Event Description

While removing the line dressing (no scissors involved, simply peeling back tape), blood gushed from what was thought to be the line insertion site.Pressure was held and the line was examined, finding that the blood was coming from the venous tubing of the line.Piece of tubing was missing/sheared off.Line removed and given to mfr for examination on (b)(6) 2017.

• Brand Name: SCHON XL DOUBLE LUMEN CATHETER
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; queensbury NY 12804
• MDR Report Key: 6607487
• MDR Text Key: 76663492
• Report Number: MW5070146
• Device Sequence Number: 1
• Product Code: MSD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/31/2017

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: Health Professional
• Device Expiration Date: 01/06/2019
• Device Catalogue Number: 10802703
• Device Lot Number: MCDA840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR