MAUDE Adverse Event Report: MEDCOMP REPAIR KIT

Model Number	RPK-01
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device involved in the incident was not returned for evaluation.The complaint information was forwarded to the engineering department for evaluation.The luer connector conforms to the current en/iso standards.Information provided stated the repair luer was used with a bard hemosplit catheter.The ifu states the device "repairs medcomp® catheters: split cath®, hemo-flow®, hemo-flow® xf, titan hd.Do not use to repair catheters other than those specified above." the repair luer was used off label.First complaint of this nature.
Event or Problem 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.The catheter needed to be replace.

• Brand Name: REPAIR KIT
• Common Device Name: REPAIR KIT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 6725877
• Report Number: 2518902-2017-00038
• Device Sequence Number: 13643745
• Product Code: NFK
• UDI-Device Identifier: 00884908039856
• UDI-Public: 884908039856
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RPK-01
• Device Catalogue Number: RPK-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention