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

Model Number	00884450295540
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/18/2020
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
Physician alleges that during a permanent dialysis catheter preparation, the red stiffening stylet could not pass through the dialysis catheter lumen.Another catheter was used for this procedure.No patient injury to report.
Additional Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.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: CENTROSFLO CATHETER
• Common Device Name: CATHETER.LONG-TERM HEMODIALYSIS,
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, ut
• MDR Report Key: 10401776
• Report Number: 1721504-2020-00050
• Device Sequence Number: 16910615
• Product Code: MSD
• UDI-Device Identifier: 00884450295540
• UDI-Public: 00884450295540
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K151967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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 Model Number: 00884450295540
• Device Catalogue Number: CENFT19K
• Device Lot Number: H1762399
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 08/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1