FDA Adverse Event Malfunction Summary report: N

3M CUROS PROTECTIVE ALCOHOL CAP

MDR report key: 23019150 · Received September 10, 2025

Report

Report Number
MW5175894
Event Type
Malfunction
Date Received
September 10, 2025
Date of Event
September 5, 2025
Report Date
September 6, 2025
Manufacturer
3M COMPANY
Product Code
QBP
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
CA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I FOUND THE GREEN 3M CUROS CAP IN MY SHIRT IN ORDER TO PREVENT BACTERIAL LINE INFECTIONS THAT ARE CAUSED BY TOUCH CONTAMINATION OF MALE NEEDLELESS INTRAVENOUS (IV) LINE TIP CONNECTORS, A HEALTHCARE WORKER MUST TWIST ON CAPS WHEN A LINE IS NOT USED. THIS PERTAINS TO CENTRAL LINES THAT ARE ACCESSED THROUGH A PORT, PERIPHERAL INSERTED CENTRAL CATHETERS (PICC), AND THE CONNECTORS USED IN HEMODIALYSIS PATIENTS. THESE PROTECTIVE CAPS CONTAIN 70% ISOPROPYL (IPA) PADS TO KEEP THE CONNECTOR TIPS STERILE. THE FREQUENTLY USED BRAND IS GREEN AND SOLD UNDER 3M CUROS. THESE CAPS CONTRARY TO THEIR ADVERTISEMENTS AND OBSERVATIONS BY HEALTHCARE WORKERS ARE DIFFICULT TO TWIST ON. THE FDA HAS RECEIVED ADVERSE EVENTS REPORTS ABOUT THEM COMING OFF AND FOUND BY PATIENTS IN THEIR BEDS, INCREASING THE RISK OF CONTAMINATION, THE RISK OF AT HOME STERILIZATION BY THE PATIENT, AND INFECTION OF THEIR CENTRAL LINES. THERE ARE TWO REASONS THE CAPS COME OFF ONE IS THAT THERE ARE NOT TWISTED ON FIRMLY ENOUGH AND THE OTHER IS WHEN THE PATIENT WEARS THE CAPED CONNECTORS UNDER THE SLEEVE OF A SHIRT OR UNDER A MESH LINE COVER, THE CAP SIDES COME IN CONTACT WITH THOSE SURFACES AND AT THE SAME TIME WITH THE PATIENTS SKIN, WHICH CAN RESULT IN REPETITIVE ROTARY MOTIONS AND LOOSENING OF THE CAP THAT IS THEN TWISTED OFF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1952292 3M CUROS PROTECTIVE ALCOHOL CAP CAP, DEVICE DISINFECTANT QBP 3M COMPANY 11052658

Patients

Seq Age Sex Outcome Treatment
1 76 YR Male