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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. MICROBORE TUBING EXTENSION SET INTRAVENOUS ADMINISTRATION TUBING EXTENSION SET

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CAREFUSION 303, INC. MICROBORE TUBING EXTENSION SET INTRAVENOUS ADMINISTRATION TUBING EXTENSION SET Back to Search Results
Catalog Number 30914
Device Problem Fluid Leak (1250)
Patient Problems Apnea (1720); Bradycardia (1751); Underdose (2542)
Event Date 12/20/2018
Event Type  malfunction  
Event Description
Preterm infant was receiving cafcit (caffeine citrate) iv every 12 hours for apnea and bradycardia episodes due to prematurity. Rn gave dose on at 2118 and noted that patient was having increased episodes of apnea and bradycardia in which the infant required mild stimulation to recover. Rn then noticed that the iv tubing was wet on the exterior and changed the iv tubing. She then attempted to flush the line and noted that there was leaking at the hub of the tubing. Infant most likely did not receive entire dose of cafcit at 2118.
 
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Brand NameMICROBORE TUBING EXTENSION SET
Type of DeviceINTRAVENOUS ADMINISTRATION TUBING EXTENSION SET
Manufacturer (Section D)
CAREFUSION 303, INC.
3750 torrey view ct
san diego CA 92130
MDR Report Key8239148
MDR Text Key132775366
Report Number8239148
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/11/2019
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number30914
Device Lot Number18025196
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/03/2019
Event Location Hospital
Date Report to Manufacturer01/11/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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