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

Lot Number 0419 0707

Device Problem Break (1069)

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

Event Date 01/31/2017

Event Type  malfunction  

Event Description

Curos cap broke in two while nurse was screwing the cap on a picc line.

• Brand Name: CUROS
• Type of Device: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): 3M COMPANY, 3M HEALTH CARE; 3m center, 2510 conway ave.; bldg. 275-5w-06; saint paul MN 55144
• MDR Report Key: 6325422
• MDR Text Key: 67236534
• Report Number: 6325422
• 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: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0419 0707
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/03/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1