MAUDE Adverse Event Report: 3M COMPANY CUROS CAPS; PAD, ALCOHOL, DEVICE DISINFECTANT

Health Effect - Clinical Code	No Information (3190)
Date of Event	02/09/2017
Type of Reportable Event	Malfunction
Event or Problem Description
A trial of 3m curos jet alcohol caps started the first week of (b)(6) 2017.Approximately 1 week into the trial, a nurse reported fluid leaking from a baxter clearlink iv tubing access port with a curos cap in place when the tubing was accidently left clamped.The event was reported to 3m to investigate the problem.Several weeks later, a second report was received of a curos cap screwed on at an angle on a baxter clearlink iv access port causing fluid to leak from the port.The leaking stopped when a cap was placed on correctly.A third report was received of a damaged hospira microclave suspected by the nurse to be associated with the curos jet cap.In a conference call with 3m representatives, we learned the 3m technical engineers were intermittently able to duplicate the leaking when the baxter clearlink tubing was put under pressure (the tubing was not pressurized above the maximum limit it is made to withstand) and a curos jet cap was in place.They also said they could create a small leak without a jet cap in place.They said they had 5 other hospitals that experienced leaks when using the jet cap and baxter clearlink tubing.Manufacturer response for caps for iv tubing, curos caps (per site reporter): date: february, 2017.Subject: reports of baxter® clearlink¿ iv access system leaking with use of 3m curos jet¿ disinfecting cap for needleless connectors.Dear valued healthcare partner, we have recently been made aware of reports that some baxter® continu-flo solution sets with clearlink¿ needleless connectors may intermittently leak from their clearlink¿ needleless connectors while under pressure when used in conjunction with 3m¿ curos jet¿ disinfecting cap for needleless connectors.We have investigated the curos jet¿ lots in question and have found them to be within our design specifications.As your healthcare partner, 3m¿ takes these reports very seriously and is vigorously investigating this issue.We have made baxter® aware of the situation and are working with them to better understand the root cause of this issue.For questions and additional information related to 3m¿ curos¿ disinfecting port protectors, please contact your local 3m sales representative, or the 3m health care customer helpline at (b)(4).Kindly, (b)(4).

• Brand Name: CUROS CAPS
• Common Device Name: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave.; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 6456187
• Report Number: 6456187
• Device Sequence Number: 633643
• Product Code: LKB
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/21/2017
• Report Date (Section F): 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: YES. THE CUROS JET CAP WAS BEING USED WITH BAXTER
• Date Report Sent to FDA: 03/15/2017