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

Model Number	00884450330241
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: PERITONEAL DIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan,, ut
• MDR Report Key: 10289910
• Report Number: 1721504-2002-00051
• Device Sequence Number: 16721944
• Product Code: FJS
• UDI-Device Identifier: 00884450330241
• UDI-Public: 00884450330241
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K071167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00884450330241
• Device Catalogue Number: VP-211
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention