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

Model Number	00884450276129
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
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
The account alleges that after one-week post hemodialysis catheter placement on a bilateral amputee patient, a clear tube was found to be protruding from within the long term dialysis catheter.The catheter has not yet been withdrawn from the patient and is still currently used during dialysis treatment as a temporary measure.The hospital in-patient dialysis procedure is extended due the deformity of the catheter.No patient injury to report.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.No definitive root cause could be determined however, it 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.
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: CENTROSFLO.LONG-TERM HEMODIALYSIS.
• Common Device Name: HEMODIALYSIS CATHETER.
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 10584504
• Report Number: 1721504-2020-00073
• Device Sequence Number: 13757713
• Product Code: MSD
• UDI-Device Identifier: 00884450276129
• UDI-Public: 00884450276129
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151967
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/07/2020

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 Expiration Date: 09/16/2022
• Device Model Number: 00884450276129
• Device Catalogue Number: CENFT23K
• Device Lot Number: H1775482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: 09/07/2020
• Supplement Date Received by Manufacturer: 12/23/2020; 05/05/2021
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 01/07/2021; 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1