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 Consequences Or Impact To Patient (2199)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product lot # was not provided, therefore manufacture date is unknown.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¿ 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 clinical nurse specialist in hematology-oncology alleged that a pool of liquid was found under a patient's bed when a patient had chemotherapy (cytoxan) infusing (200ml bag over 2 hours) that was piggy backed into a y-site of the primary tubing of a triple lumen hickman catheter.The y-site, closest to the patient, which had a curos jet¿ disinfecting cap for needleless connectors on it reportedly leaked.The medication was re-dosed for the patient.

• 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: 9252231
• Report Number: 2110898-2019-00127
• Device Sequence Number: 16687273
• Product Code: LKB
• UDI-Device Identifier: 30707387773824
• UDI-Public: 30707387773824
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/29/2019

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 Model Number: N/A
• Device Catalogue Number: CFJ1-270
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR