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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MAXPLUS® CLEAR NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION MAXPLUS® CLEAR NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MP1000-C
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
The sets have not been sequestered by the customer. Because no product was returned or expected to be returned, no failure investigation could be performed. The root cause of the customer's experience was not identified.
 
Event Description
The customer reported that "in the last month the nurses are reporting that they are having difficulty removing the device from the lines and are having to send the clients to hospital to have them removed". The customer is a pharmacy that provides home care services; the description is interpreted to mean that the homecare nurses are having to send homecare patients to a higher level of care to address the issue.
 
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Brand NameMAXPLUS® CLEAR NEEDLELESS 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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key5407360
MDR Text Key37385077
Report Number9616066-2016-00208
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K072542
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/13/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMP1000-C
Device Catalogue NumberMP1000-C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2016
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 Treatment Data
Date Received: 02/03/2016 Patient Sequence Number: 1
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