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

Model Number 00884450330159

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

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

Event Date 08/03/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The account alleges that after implanting a peritoneal dialysis catheter in a pediatric patient they experienced issues with leaking.Multiple attempts were made to minimize the leaking; however, they were unsuccessful.Contrast study showed excessive leaking two weeks after implant.The catheter was removed and showed that the catheter had broken into two halves and separated just below the cuff.The patient was treated for exit site infection with oral antibiotics and a new device was implanted.

Manufacturer Narrative

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

• 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: 15254803
• MDR Text Key: 305433233
• Report Number: 1721504-2022-00073
• Device Sequence Number: 1
• Product Code: FJS
• UDI-Device Identifier: 00884450330159
• UDI-Public: 00884450330159
• 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,Followup
• Report Date: 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450330159
• Device Catalogue Number: CF-5250/C
• Device Lot Number: H2203195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2022
• 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