MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) DIALYSIS; CATHETER, HEMODIALYSIS, IMPLANTED

Device Problems Fluid/Blood Leak (1250); Defective Device (2588)

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

Event Date 05/09/2018

Event Type  malfunction  

Event Description

The patient came to the inu because her dialysis catheter was leaking from one of the ports.The patient was scheduled for a tunneled catheter exchange and when the catheter was removed from the patient, it was noted that the catheter was leaking from the venous port.It appears that the molding of the venous port where the plastic catheter goes into the white hub is where the defect in the catheter is.The catheter was exchanged with a new catheter, over a wire.

• Brand Name: DIALYSIS
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); 2400 bernville road; reading PA 19605
• MDR Report Key: 8013686
• MDR Text Key: 125308636
• Report Number: 8013686
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/15/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10950 DA