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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION 303, INC. BD MAXZERO; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION 303, INC. BD MAXZERO; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZ5309
Device Problems Crack (1135); Fluid/Blood Leak (1250); Defective Device (2588); Difficult to Open or Close (2921)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/24/2023
Event Type  malfunction  
Event Description
Blood pigtail to draw blood is defective.Difficulty removing the end cap to connect to the iv.When removal of the cap - repeated on multiple maxzero extension sets - the plastic luer end cracks and then when connected to the iv, blood leaks out and around the cracks.This happened to one patient and nurse, and the defective maxzero was removed and the iv was connected to iv tubing and not the maxzero extension set.This defect with difficult to remove end cap with potential to crack and damage the luer end has occurred in multiple different departments all with the same complaint of defect with inability to remove the end cap and risking cracking damage to the luer end.
 
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Brand Name
BD MAXZERO
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION 303, INC.
10020 pacific mesa blvd
san diego CA 92121
MDR Report Key16901910
MDR Text Key314913885
Report Number16901910
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 04/27/2023,04/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberMZ5309
Device Catalogue NumberMZ5309
Device Lot Number22099411
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/27/2023
Date Report to Manufacturer05/10/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/10/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient SexFemale
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