MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. PERITONEAL DIALYSIS CATHETER; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION.

Catalog Number	CF-5460/C
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2021
Type of Reportable Event	Serious Injury
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 post-placement of a peritoneal dialysis catheter on (b)(6) 2021.The customers homecare nurse reported on 02-23-2021 that the catheter had detached outside the patient body and a bad odor and drainage was noted.The patient was transferred to the hospital immediately for a pd catheter replacement.Antibiotics were administered for this patient.No patient injury to report.
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The complaint was confirmed; however, the root cause could not be determined although it is most likely due to use of the device.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: PERITONEAL DIALYSIS CATHETER
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION.
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 11509943
• Report Number: 1721504-2021-00017
• Device Sequence Number: 12065096
• Product Code: DRE
• UDI-Device Identifier: 00884450330210
• UDI-Public: 884450330210
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K070730
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2023
• Device Catalogue Number: CF-5460/C
• Device Lot Number: H1856197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention