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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. CENTROS LONG TERM HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED
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MERIT MEDICAL SYSTEMS INC. CENTROS LONG TERM HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED Back to Search Results
Catalog Number CENT23K
Medical Device Problem Code Difficult to Insert (1316)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/25/2021
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 review of the device history and complaint database could not be performed since the lot number was not provided.
 
Event or Problem Description
The account alleges that the stylet could not be passed through the catheter.No patient injury to report.
 
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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 Key12200012
Report Number1721504-2021-00056
Device Sequence Number4173357
Product Code MSD
UDI-Device Identifier00884450276242
UDI-Public884450276242
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K151967
Number of Events Summarized1
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 Catalogue NumberCENT23K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/12/2021
Initial Report FDA Received Date07/20/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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