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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION PRIMARY TUBING SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION PRIMARY TUBING SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number PRI TUBING
Device Problems Fluid Leak (1250); Material Separation (1562); Insufficient Flow or Under Infusion (2182)
Patient Problem Underdose (2542)
Event Type  malfunction  
Manufacturer Narrative
Age: baby. Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
It was reported when connecting this tubing up to the tpn. The tubing pulled away from the drip chamber which allowed all the fluid to spill. The patient was not able to get the nutrients required.
 
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Brand NamePRIMARY TUBING SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9690726
MDR Text Key191557680
Report Number9616066-2020-00438
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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