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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. LONG TERM DIALYSIS CATHETER REPAIR KIT; KIT, REPAIR, CATHETER, HEMODIALYSIS
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MEDICAL COMPONENTS, INC. LONG TERM DIALYSIS CATHETER REPAIR KIT; KIT, REPAIR, CATHETER, HEMODIALYSIS Back to Search Results
Catalog Number RPK-01
Device Problems Device Contamination With Biological Material (2908); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2017
Event Type  malfunction  
Event Description
Subsequent to utilization of the catheter luer lock dual lumen dialysis catheter repair kit, the catheter was connected to the extra corporeal circuit and dialysis treatment was initiated.At this time, foam was noticed in the blood circuit originating at the hub.Multiple attempts to tighten the connection were unsuccessful.Catheter needed to be replaced.Inspection of the repaired catheter connector revealed fewer threads than the norm, the threads at a less of a pitch and also less spacing between the threads.Manufacturer response for dual lumen dialysis catheter repair kit, medcomp (per site reporter): no action taken at this time by medcomp.
 
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Brand Name
LONG TERM DIALYSIS CATHETER REPAIR KIT
Type of Device
KIT, REPAIR, CATHETER, HEMODIALYSIS
Manufacturer (Section D)
MEDICAL COMPONENTS, INC.
1499 delp drive
harleysville PA 19438
MDR Report Key6590652
MDR Text Key75948708
Report Number6590652
Device Sequence Number1
Product Code NFK
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2017
Is this a Product Problem Report? Yes
Device Operator Nurse
Device Catalogue NumberRPK-01
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/02/2017
Event Location Hospital
Date Report to Manufacturer05/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
DIALYSIS; PATIENT DIALYZING AT THE TIME OF THE INCIDENT.
Patient Outcome(s) Other;
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