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

Model Number	00884450330159
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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®
• Common Device Name: 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
• Report Number: 1721504-2022-00073
• Device Sequence Number: 6664016
• Product Code: FJS
• UDI-Device Identifier: 00884450330159
• UDI-Public: 00884450330159
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K970159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown