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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 3M COMPANY CUROS; PAD, ALCOHOL, DEVICE DISINFECTANT
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3M COMPANY CUROS; PAD, ALCOHOL, DEVICE DISINFECTANT Back to Search Results
Catalog Number CFF10-250
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/27/2019
Event Type  malfunction  
Event Description
Patient with picc line had green, disinfecting end cap over picc line needleless connector, per standard.When rn attempted to removed/unscrew the green, disinfecting end cap, it broke into two pieces and part of the green, disinfecting end cap was stuck/remained on the picc line needleless connector.Rn was unable to get the piece of the green, disinfecting end cap off and the picc line needleless connector had to be changed by the vascular access team rn.
 
Event Description
Patient with picc line had green, disinfecting end cap over picc line needleless connector, per standard.When rn attempted to removed/unscrew the green, disinfecting end cap, it broke into two pieces and part of the green, disinfecting end cap was stuck/remained on the picc line needleless connector.Rn was unable to get the piece of the green, disinfecting end cap off and the picc line needleless connector had to be changed by the vascular access team rn.
 
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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 Key9543678
MDR Text Key173484502
Report Number9543678
Device Sequence Number1
Product Code LKB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup
Report Date 12/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCFF10-250
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/03/2019
Event Location Hospital
Date Report to Manufacturer01/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age26280 DA
Patient Weight126
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