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

Catalog Number CFF1-270R

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Information was not provided by reporter.Date of event: information was not provided by reporter.

Event Description

A pediatric icu department in (b)(6) reported a small green particle broke off from a cff1-270r curos cap and was aspirated out of a patient's iv tubing lumen.No patient injury was reported.

Manufacturer Narrative

No information was provided regarding use of a needless connector.

• Brand Name: 3M CUROS DISINFECTING CAP FOR NEEDLELESS CONNECTORS
• Type of Device: CUROS DISINFECTING CAP FOR NEEDLELESS CONNECTORS
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY 3M COLUMBIA; 5400 paris road; columbia MO 65202
• Manufacturer Contact: karen krenik, bsn ; 3m center building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517333091
• MDR Report Key: 6873466
• MDR Text Key: 86617388
• Report Number: 2110898-2017-00118
• Device Sequence Number: 1
• Product Code: LKB
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2019
• Device Catalogue Number: CFF1-270R
• Device Lot Number: 20160612-03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1