MAUDE Adverse Event Report: MEDCOMP REPAIR KIT

Model Number RPK-01

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated.When the investigation is complete a final report will be submitted.

Event Description

Blood leakage at the connection between the luer and the blood tubing set.This can be counteracted by a tightening of the connection.There have been no disconnections.

Manufacturer Narrative

Root cause determined by the contract manufacturer and medcomp engineering: an evaluation of affected samples indicated an imperfect thread form, not passing iso-594-2 standard.The identified the root cause was the thread insert was not being properly ground.Corrective/preventative actions: the drawing for the luer was revised to depict correct luer thread, to add thread details and dimensions, and to add inspection keys to identify critical dimensions.Inspection of the threading insert next to the drawing.A 100% inspection of the luer taper and luer thread at the machine was instituted.A 100% inspection for final inspection of both luer characteristics prior to shipment.Implementation of the iso 80369-7 thread gage(s).

• Brand Name: REPAIR KIT
• Type of Device: REPAIR KIT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7236872
• MDR Text Key: 99002371
• Report Number: 2518902-2018-00003
• Device Sequence Number: 1
• Product Code: NFK
• UDI-Device Identifier: 00884908039856
• UDI-Public: 884908039856
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 07/20/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 08/01/2022
• Device Model Number: RPK-01
• Device Catalogue Number: RPK-01
• Device Lot Number: MCFH990
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NIKKISO BLOOD LINES
• Patient Outcome(s): Required Intervention