Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MAXZERO NEEDLELESS CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION MAXZERO NEEDLELESS CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZ1000-07
Device Problem Fluid/Blood Leak (1250)
Patient Problem Underdose (2542)
Event Date 02/12/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: used 2.5ml covidien monoject syringe, lot: 19i1124, exp: 2021-08-31, 0.9% sodium chloride; non-bd extension set; td (b)(6) 2020.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.
 
Event Description
It was reported that there was a leak between the maxzero and a non-bd syringe.The event occurred in the cvicu.It was reported that patient did not receive the full dose of antibiotic as a result.There was no patient or user harm.The event did not cause a delay that significantly impacted patient outcome.Although requested, no patient information provided.
 
Event Description
It was reported that there was a leak between the maxzero and a non-bd syringe.The event occurred in the cvicu.It was reported that patient did not receive the full dose of antibiotic as a result.There was no patient or user harm.The event did not cause a delay that significantly impacted patient outcome.Although requested, no patient information provided.
 
Manufacturer Narrative
The customer¿s report of leak at connection between the maxzero and a non-bd syringe was not confirmed.All of the components were inspected under a microscope for any cracks, fractures, or stress marks.No anomalies were observed on the set during visual inspection.Functional testing showed no anomalies.The received component and female/male luer ports from the extension set were measured and were within iso standards.The root cause of the customer's report was not identified.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9856766
MDR Text Key188882414
Report Number9616066-2020-00825
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,other
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/26/2022
Device Model NumberMZ1000-07
Device Catalogue NumberMZ1000-07
Device Lot Number19107081
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
10014914, TD (B)(6) 2020
-
-