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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SMALLBORE Y-CONNECTOR EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION SMALLBORE Y-CONNECTOR EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 20019E
Device Problem Component Missing (2306)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/26/2019
Event Type  malfunction  
Manufacturer Narrative
The affected product has been received and the investigation is pending. A follow up report will be submitted once the failure investigation has been completed. Although requested, no specific patient information was provided.
 
Event Description
It was reported that a set was missing an end during use. There was no patient harm.
 
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Brand NameSMALLBORE Y-CONNECTOR EXTENSION 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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9227451
MDR Text Key165262839
Report Number9616066-2019-02990
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061285
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 10/01/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20019E
Device Catalogue Number20019E
Device Lot Number19065923
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2019
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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