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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 MZ1000-07
Device Problem Obstruction of Flow (2423)
Patient Problem No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative
No product will be returned per customer because the product was discarded.Although requested, no patient demographics were provided.
 
Event Description
It was reported that there were maxzeros that clotted, contributing to loss of central iv access.Although requested, customer was unable to provide any event or patient specific information.
 
Manufacturer Narrative
Correction: d.5.
 
Event Description
It was reported that there were maxzeros that clotted, contributing to loss of central iv access.Although requested, customer was unable to provide any event or patient specific information.
 
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Brand Name
MAXZERO NEEDLELESS CONNECTOR
Type of Device
SET, ADMINISTRATION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key10041635
MDR Text Key190494858
Report Number9616066-2020-01627
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403230196
UDI-Public10885403230196
Combination Product (y/n)N
PMA/PMN Number
K132413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMZ1000-07
Device Catalogue NumberMZ1000-07
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/10/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CENTRAL IV ACCESS CATHETER, TD UNK
Patient Outcome(s) Other;
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