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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 Problem Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/17/2019
Event Type  malfunction  
Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
It was reported that the blue silicone inside the connector was not retracting after being flushed.
 
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Brand Name
MAXPLUS POSITIVE PRESSURE CONNECTOR
Type of Device
SET, 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 Key8609269
MDR Text Key145018389
Report Number9616066-2019-01303
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403223228
UDI-Public10885403223228
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 Nurse
Type of Report Initial
Report Date 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMP1000-C
Device Catalogue NumberMP1000-C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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