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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. CENTROSFLO LONG TERM HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED
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MERIT MEDICAL SYSTEMS, INC. CENTROSFLO LONG TERM HEMODIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED Back to Search Results
Catalog Number CENF19K
Device Problems Occlusion Within Device (1423); Improper Flow or Infusion (2954)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/19/2014
Event Type  malfunction  
Event Description
The user reported that a pt was seen with a hemodialysis catheter that was not flowing correctly.No fibrin sheath was visualized during fluoroscopy.The catheter was exchanged, a clot was seen on the end of the catheter after removal.No pt harm or injury was reported.
 
Manufacturer Narrative
Device eval: no device is expected to be returned for eval.The user did not provide a lot number.A review of the device history record and complaint database could not be completed.Merit is unable to determine a root cause without the returned device.
 
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Brand Name
CENTROSFLO LONG TERM HEMODIALYSIS CATHETER
Type of Device
CATHETER, HEMODIALYSIS, IMPLANTED
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
south jordan UT
Manufacturer Contact
jerry mcphie
1600 west merit pkwy.
south jordan, UT 84095
8012084491
MDR Report Key3871747
MDR Text Key4457250
Report Number1721504-2014-00082
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K092597
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 03/21/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCENF19K
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/21/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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