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

Model Number 00884450375006

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A lot number was reported, and a review of the manufacturing history record is in progress.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a peritoneal dialysis catheter placement procedure on an infant, the peritoneal dialysis catheter broke while prepping the device for deployment.Another pd catheter was successfully prepped and placed within the patient.No patient injury to report.

Manufacturer Narrative

The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.

• Brand Name: PERITONEAL DIALYSIS CATHETER
• Type of Device: LONG TERM DIALYSIS CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 10742916
• MDR Text Key: 217366944
• Report Number: 1721504-2020-00088
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 00884450375006
• UDI-Public: 00884450375006
• Combination Product (y/n): N
• PMA/PMN Number: K031351
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 00884450375006
• Device Catalogue Number: CF-4235/D
• Device Lot Number: H1698517
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1