MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ CUROS JET¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS; CUROS JET DISINFECTING CAP

Model Number	N/A
Medical Device Problem Code	Accessory Incompatible (1004)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient-specific information was not provided.3m found this to be an intermittent incompatibility issue associated with the impact of system pressure on select needleless connector.Current product labeling notes the potential for intermittent leaking with baxter® continu-flo¿ solution set with clearlink¿ luer activated valve.Please see the exact wording below: caution: there is a potential for intermittent leaking when baxter® continu-flo(tm) solution set with clearlink¿ luer activated valve or bd maxzero¿ needle-free connectors are used under pressure with 3m¿ curos jet¿ disinfecting caps (cfj1-270 and cfj5-250.) monitor these connectors if used under pressure.Alternatively, 3m¿ curos¿ disinfecting cap for needleless connectors (cff1-270 and cff10- 250) may be used.
Event or Problem Description
A hospital materials manager alleged 4-5 incidents of fluid leakage that began when they switched to using baxter i.V.Chemotherapy tubing in (b)(6) 2019 and have been using curos jet¿ disinfecting cap for needleless connectors.The hospital staff provided information regarding four alleged incidents: a wet spot was found on the floor and the port closest to the patient was found to be leaking, an i.V.Found to be leaking out of the port with the curos jet¿ disinfecting cap on it where the i.V.Tubing was changed with no further leakage, leakage around the curos jet¿ disinfecting cap, and chemotherapy leakage from under a port underneath the curos jet¿ disinfecting cap where the primary i.V.Line had normal saline infusing and a secondary line was piggy-backed into a y-site and infused into a picc line, where a nurse was present and noticed the leaking, stopped the infusion right away, and ordered another chemotherapy bag to infuse.Patient-specific information was not provided.

• Brand Name: 3M¿ CUROS JET¿ DISINFECTING CAP FOR NEEDLELESS CONNECTORS
• Common Device Name: CUROS JET DISINFECTING CAP
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• MDR Report Key: 9185865
• Report Number: 2110898-2019-00118
• Device Sequence Number: 16837879
• Product Code: LKB
• UDI-Device Identifier: 30707387773831
• UDI-Public: 30707387773831
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2022
• Device Model Number: N/A
• Device Catalogue Number: CFJ5-250
• Device Lot Number: 6532163
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1