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

Lot Number 08210728

Device Problems Break (1069); Entrapment of Device (1212)

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

Event Date 01/23/2019

Event Type  malfunction  

Event Description

Green curos cap broke when being applied to leur lock.Small green circle broke from bottom of cap and stuck to leur lock.Had to use hemostats to take piece back off.Round green piece with antiseptic sponge remained intact.

• Brand Name: CUROS
• Type of Device: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): 3M COMPANY; 3m center, 2510 conway ave.; bldg. 275-5w-06; st. paul MN 55144
• MDR Report Key: 8343051
• MDR Text Key: 136276417
• Report Number: 8343051
• Device Sequence Number: 1
• Product Code: LKB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/08/2019

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
• Device Operator: Health Professional
• Device Lot Number: 08210728
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1