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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION 303, INC. MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZ1000-07
Device Problems Crack (1135); Fluid Leak (1250)
Patient Problem Missed Dose (2561)
Event Date 09/14/2020
Event Type  malfunction  
Event Description
A one-time dose of fentanyl was initiated at 0505 to be given prior to intubation. The dose was initiated, and the intubation process was started. Upon hanging a saline flush, the nurse discovered that there was a crack in the clave/ med tubing and the fentanyl had puddled on the ground below the syringe pump. A re-dose of fentanyl was required, and the intubation was traumatic as a result of the failed infusion of the first dose. The neonatal nurse practitioner was at the bedside and was notified immediately of the event. The charge nurse was also made aware and was at the bedside.
 
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Brand NameMAXZERO NEEDLELESS CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd
san diego CA 92121
MDR Report Key10552982
MDR Text Key207539449
Report Number10552982
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMZ1000-07
Device Catalogue NumberMZ1000-07
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/15/2020
Event Location Hospital
Date Report to Manufacturer09/18/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 09/18/2020 Patient Sequence Number: 1
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