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

Device Problem Break (1069)

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

Event Date 08/06/2019

Event Type  malfunction  

Event Description

Curos cap was being changed and during the change the cap broke apart.Cap was still able to be removed and no further event occurred.Manufacturer response for curos cap, curos cap for male luer (per site reporter) : unknown.

• 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: 8939408
• MDR Text Key: 155843909
• Report Number: 8939408
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/14/2019,08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/14/2019
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1