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	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event not provided.Date event was reported to distributor used as the event date.The product has not been received by 3m for evaluation.Without the actual samples observed to be leaking, or additional information on the system set-up, the exact root cause cannot be identified.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 distributor reported that a patient had dobutamine infusing through an internal jugular catheter with partial occlusion and had leaking at the curos jet¿ disinfecting caps y-site.No patient harm occurred.No additional information was 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: 9333361
• Report Number: 2110898-2019-00134
• Device Sequence Number: 16670371
• 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: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2019

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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/17/2019
• 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: Congenital Anomaly