MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. FLEX-NECK®; CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number 00884450330166

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

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

Event Date 12/15/2022

Event Type  malfunction  

Event Description

The account alleges that a peritoneal dialysis procedure the physician was able to place the catheter without trouble.Once the physician went to flush the catheter he noticed it was leaking.The physician placed a purse string suture and tried again and the catheter continued to leak.Physician decided to remove the catheter and place another catheter.Once the physician removed the initial catheter he attempted to flush it and the catheter had a hole in it.

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Manufacturer Narrative

The suspect medical device was returned for evaluation.The complaint is confirmed.The root cause is attributed to significant force from a hemostat or clamp being applied to the device during use.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: FLEX-NECK®
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• 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: 16016300
• MDR Text Key: 306343968
• Report Number: 1721504-2022-00106
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K970159
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450330166
• Device Catalogue Number: CF-5260/C
• Device Lot Number: H2369133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1