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

Model Number 00884450330166

Device Problems Fracture (1260); Material Fragmentation (1261)

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

Event Date 05/15/2020

Event Type  malfunction  

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 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
• Type of Device: PERITONEAL DIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan, ut
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 merit parkway; south jordan, ut
• Manufacturer Contact: david lockridge ; 1600 merit parkway; south jordan, ut
• MDR Report Key: 10141381
• MDR Text Key: 198892066
• Report Number: 1721504-2020-00035
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 00884450330166
• UDI-Public: 00884450330166
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K970159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1