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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZ1000
Device Problems Backflow (1064); Obstruction of Flow (2423)
Patient Problem Extravasation (1842)
Event Date 04/20/2019
Event Type  malfunction  
Manufacturer Narrative
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 mz1000-07. The 510k number provided in section g5 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 reported feedback suggests that the device with extravasation of medication, serum at the insertion. From the reported information, the extent of patient injury as result of the extravasation has not been clarified.
 
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Brand NameMAXZERO 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 Key8608683
MDR Text Key145002755
Report Number9616066-2019-01324
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K132413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial
Report Date 04/23/2019
1 Device was Involved in the Event
0 Patients were 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
Device Expiration Date09/25/2020
Device Model NumberMZ1000
Device Catalogue NumberMZ1000
Device Lot Number17097339
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/25/2017
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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