3M? CUROS? DISINFECTING CAP FOR NEEDLELESS CONNECTORS N/A CFF1-270R

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for 3M? CUROS? DISINFECTING CAP FOR NEEDLELESS CONNECTORS N/A CFF1-270R manufactured by 3m Health Care.

Event Text Entries

[144153097] A customer reported that a curos? Disinfecting cap was attached directly to a hickman line and mw 2110898-2019-00071 was submitted for that report. The customer reported during their investigation of that report, it was found that this occurred, an unspecified number of times, at other hospitals within their network. No individual information was provided regarding the additional reports. The customer reported re-education occurred at each hospital. Mw 2110898-2019-00072 was submitted for this additional report. Both the product packaging and the instructions for use (ifu) for 3m? Curos? Disinfecting cap for needleless connectors instruct that the product is only to be used on needleless connectors. Primary packaging: in multiple locations on the primary package, the product name and descriptor indicates the product is to be used with needless connectors. The generic descriptor "disinfecting cap for needless connectors" is translated in 27 languages. The packaging also includes the "warning, see ifu" symbol, which should direct the user to the ifu for full warning information. Ifu: information regarding the use with needless connectors can be found in multiple locations within the ifu, in bold lettering. Product name and generic descriptor 3m? Curos? Disinfecting cap for needleless connectors (translated into 27 languages). Intended use: the curos? Disinfecting cap is intended for use on needleless connectors only. Warning: to avoid potential for injury - use only on needleless connectors. Product packaging includes graphics instructing customers to apply the curos cap only to needleless connectors and not to apply the curos cap directly to a catheter hub. In addition, 3m provides training materials (including graphics) instructing customers to apply the curos cap only to needleless connectors and not to apply the curos cap directly to a catheter hub.
Patient Sequence No: 1, Text Type: N, H10


[144153098] 3m europe (eu) received a report from the eu authorities (mhra). A customer noted in a report that there was an unspecified number of incidents where a cff1-270r 3m? Curos? Disinfecting cap for needleless connector was attached directly to a hickman line at different hospitals within their network. The customer reported re-education was provided. No specific information was provided related to the individual incidents.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2110898-2019-00072
MDR Report Key8577760
Date Received2019-05-03
Date of Report2019-05-03
Date Mfgr Received2019-04-08
Date Added to Maude2019-05-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDIANNE GIBBS
Manufacturer Street3M CENTER BUILDING 275-5W-06 2510 CONWAY AVE
Manufacturer CityST. PAUL MN 55144
Manufacturer CountryUS
Manufacturer Postal55144
Manufacturer Phone6517379117
Manufacturer G13M COMPANY 3M COLUMBIA
Manufacturer Street5400 PARIS ROAD
Manufacturer CityCOLUMBIA MO 65202
Manufacturer CountryUS
Manufacturer Postal Code65202
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand Name3M? CUROS? DISINFECTING CAP FOR NEEDLELESS CONNECTORS
Generic NameCUROS DISINFECTING CAP FOR NEEDLELESS CONNECTORS
Product CodeLKB
Date Received2019-05-03
Model NumberN/A
Catalog NumberCFF1-270R
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
Manufacturer3M HEALTH CARE
Manufacturer Address2510 CONWAY AVE ST. PAUL MN 55144 US 55144


Patients

Patient NumberTreatmentOutcomeDate
10 2019-05-03

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