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

Model Number 00884450330241

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device was not returned for evaluation.The patient is still using the device.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 Description

The account alleges that a patient had a peritoneal dialysis catheter placed.The catheter was not working so the patient returned to the hospital.The patient was admitted for a laparoscopic scope procedure.The physician found that catheter had adhered to the peritoneal wall of the patient.The physician also noted that a catheter guide assembly was left within the patient from the last implant procedure.The assembly was removed from the patient and the physician completed some minor maintenance on the catheter.The pd catheter was left within the patient for continued use.The physician stated that there were no signs of infection.No patient injury 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 ; 2084551
• MDR Report Key: 10289910
• MDR Text Key: 199285047
• Report Number: 1721504-2002-00051
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 00884450330241
• UDI-Public: 00884450330241
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071167
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450330241
• Device Catalogue Number: VP-211
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention