MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. FLEX NECK PERITONEAL DIALYSIS CATHETER; PD CATHETER

Catalog Number CF-5260

Device Problems Fracture (1260); Material Perforation (2205)

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

Event Date 11/24/2021

Event Type  Injury  

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.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned at a later date, the investigation will be re-opened.

Event Description

The account alleges that post pd catheter placement, the catheter became damaged and detached within the patient.Placement was completed in october without any concerns.Admission was necessary 4 weeks post implant procedure.

• Brand Name: FLEX NECK PERITONEAL DIALYSIS CATHETER
• Type of Device: PD CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 12902235
• MDR Text Key: 283244458
• Report Number: 1721504-2021-00081
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 00884450170199
• UDI-Public: 884450170199
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K970159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CF-5260
• Date Manufacturer Received: 11/24/2021
• 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; Required Intervention