MAUDE Adverse Event Report: 3M COMPANY CUROS JET; PAD, ALCOHOL, DEVICE DISINFECTANT

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/25/2018

Event Type  malfunction  

Event Description

Green curos caps broke when placed onto luer lock.This occurred on two different patients with two different nurses.Both were able to be removed and a new cap placed.There was no harm to the patient.

• Brand Name: CUROS JET
• Type of Device: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave.; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 7577474
• MDR Text Key: 110339047
• Report Number: 7577474
• Device Sequence Number: 1
• Product Code: LKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Other Device ID Number: 0321 AND 0707 WERE ON THE CAP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/31/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1