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	Underdose (2542)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 nurse reported 3m¿ curos jet¿ disinfecting caps were placed on the needleless connector ports of a patient's iv tubing.The nurse reported a curos cap "failed" on one of the needleless connector ports and a puddle of propofol iv medication was found on the floor underneath the iv port.The nurse reported this resulted in the patient not receiving the appropriate dose of medication.No additional information has been received to date.

• 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: 8565291
• Report Number: 2110898-2019-00069
• Device Sequence Number: 2339342
• Product Code: LKB
• UDI-Device Identifier: 30707387773824
• UDI-Public: 30707387773824
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: CFJ1-270
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 04/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BAXTER CLEARLINK CONTINU-FLO SOLUTION SET; ONELINK NEEDLELESS CONNECTORS
• Outcome Attributed to Adverse Event: Other