MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. LONG-TERM HEMODIALYSIS CATHETER

Catalog Number	CENFP19K
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
The account alleges that approximately one-month post dialysis catheter implant; the catheter was leaking.The patient returned to the clinic for catheter replacement.No injury to report.

• Brand Name: LONG-TERM HEMODIALYSIS CATHETER
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• MDR Report Key: 9176890
• Report Number: 1721504-2019-00086
• Device Sequence Number: 16792144
• Product Code: MSD
• UDI-Device Identifier: 00884450038185
• UDI-Public: 00884450038185
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K141363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: CENFP19K
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 10/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1