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

Model Number	00884450170199
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/05/2020
Type of Reportable Event	Serious Injury
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 post-peritoneal dialysis catheter placement; the patient presented with an infection at time of catheter removal.The physician states that the catheter implant site was likely the cause of the infection.Medical intervention for the infection was necessary.During the catheter removal the dermal cuff detached within the patient rectus muscle.The physician administered additional anesthetic for patient comfort, and the foreign body was surgically removed.The patient tolerated the procedure well with no other 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: 10096993
• Report Number: 1721504-2020-00028
• Device Sequence Number: 3407349
• Product Code: FJS
• UDI-Device Identifier: 00884450170199
• UDI-Public: 00884450170199
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 00884450170199
• Device Catalogue Number: CF-5260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 05/28/2020
• 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