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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 MP1000C-0006
Device Problem Disconnection (1171)
Patient Problems Chest Pain (1776); Dyspnea (1816)
Event Date 09/06/2017
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: extension set 20 cm bbraun and central line catheter - vygon nutricath s; therapy date: (b)(6) 2017. (b)(4). The model#/catalog# identified is a carefusion product which is same or similar to a device that is approved for sale domestically. The domestic similar list number is indicated in "other#". The 510k number provided is for the domestic similar product. Although requested, device has not been received. A follow up report will be submitted with failure investigation results should the logs/device be received for evaluation.
 
Event Description
The report suggests that the patient presented with dyspnea and mild chest pain. On further investigation, it was identified that the mp1000c-0006 had disconnected from the connecting product. The information received indicates that the patient was administered oxygen and an ecg was performed.
 
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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 Key6925660
MDR Text Key88744766
Report Number9616066-2017-01331
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K072542
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 09/18/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMP1000C-0006
Device Catalogue NumberMP1000C-0006
Device Lot Number17056458
Other Device ID NumberMP1000-C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/15/2017
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: 10/06/2017 Patient Sequence Number: 1
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