MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. CENTROS LONG TERM HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number	CENFT23K
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.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.Corrective actions are in process.
Event or Problem Description
The account alleges that the stylet could not be passed through the catheter and got stuck at the hub.The unit was replaced and successfully allowed for the passing through of a stylet.No patient injury to report.

• Brand Name: CENTROS LONG TERM HEMODIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 12200011
• Report Number: 1721504-2021-00055
• Device Sequence Number: 4173356
• Product Code: MSD
• UDI-Device Identifier: 00884450276129
• UDI-Public: 884450276129
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/12/2021

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: 07/09/2023
• Device Catalogue Number: CENFT23K
• Device Lot Number: H1947512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1