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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MICROBORE EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION MICROBORE EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZ9226
Device Problem Cut In Material (2454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The customer¿s report of severed tubing was confirmed. Visual inspection confirmed a cut in the tubing approximately 1 inch above the male luer. The cut does not look clean; the area around the cut looks dark and melted. Functional testing could not be performed due to the cut on the set. The probable cause of the severed tubing is that the tubing came in contact with something hot which melted and cut the tubing.
 
Event Description
The customer reported an iv tubing was severed at the clamp. There was no report of patient involvement.
 
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Brand NameMICROBORE EXTENSION SET
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 Key6195877
MDR Text Key63065484
Report Number9616066-2016-01865
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140831
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMZ9226
Device Catalogue NumberMZ9226
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2016 Patient Sequence Number: 1
Treatment
MZ1000-07
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