MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. PERITONEAL DIALYSIS CATHETER

Model Number	00884450330166
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2020
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 search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
Event or Problem Description
The account alleges during a procedure, while tunneling the catheter to the exit site, the catheter broke at the first cuff.The cuff was successfully removed from the patient.The patient tolerated the procedure well with no additional consequences to report.

• Brand Name: PERITONEAL DIALYSIS CATHETER
• Common Device Name: PERITONEAL DIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan, ut
• MDR Report Key: 10141381
• Report Number: 1721504-2020-00035
• Device Sequence Number: 16969089
• Product Code: FJS
• UDI-Device Identifier: 00884450330166
• UDI-Public: 00884450330166
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K970159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2020

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 Expiration Date: 11/30/2022
• Device Model Number: 00884450330166
• Device Catalogue Number: CF-5260/C
• Device Lot Number: H1722550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2020
• Initial Report FDA Received Date: 06/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1