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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MAXPLUS POSITIVE PRESSURE CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION MAXPLUS POSITIVE PRESSURE CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MP1000-C
Device Problems Fluid Leak (1250); Retraction Problem (1536)
Patient Problem No Information (3190)
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. Patient demographics not provided.
 
Event Description
The set was received as an unexpected return with a report that maxplus valve not closing and leak. Although requested there was no other additional event details provided.
 
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Brand NameMAXPLUS POSITIVE PRESSURE CONNECTOR
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 Key8850462
MDR Text Key154132730
Report Number9616066-2019-02130
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K072542
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 07/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMP1000-C
Device Catalogue NumberMP1000-C
Device Lot Number19016677
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2019
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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