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U.S. Department of Health and Human Services

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

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MERIT MEDICAL SYSTEMS INC. LONG-TERM HEMODIALYSIS CATHETER Back to Search Results
Catalog Number CENFP19K
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2019
Event Type  malfunction  
Manufacturer Narrative
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
 
Event Description
The account alleges that approximately one-month post dialysis catheter implant; the catheter was leaking.The patient returned to the clinic for catheter replacement.No injury to report.
 
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Brand Name
LONG-TERM HEMODIALYSIS CATHETER
Type of Device
HEMODIALYSIS CATHETER
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan, UT 84095
Manufacturer (Section G)
MERIT MEDICAL SYSTEMS INC.
1600 merit parkway
south jordan, UT 84095
Manufacturer Contact
david lockridge
1600 merit parkway
south jordan, UT 84095
8012084551
MDR Report Key9176890
MDR Text Key163048333
Report Number1721504-2019-00086
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00884450038185
UDI-Public00884450038185
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K141363
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Physician
Type of Report Initial
Report Date 09/19/2019
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
Device Operator Health Professional
Device Catalogue NumberCENFP19K
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/19/2019
Initial Date FDA Received10/10/2019
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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