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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MINIBORE PRESSURE REMOVABLE IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION MINIBORE PRESSURE REMOVABLE IV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZ5302
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/29/2018
Event Type  malfunction  
Manufacturer Narrative
The affected product has been received and the investigation is pending. A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
The customer reported the hub of the t-connector that was used on an arterial line cracked and the patient lost blood through the crack. There was no patient harm.
 
Manufacturer Narrative
The customer¿s report of a crack in the hub was confirmed. Visual inspection of the set did not reveal any damage or abnormalities. Examination under magnification showed a thin crack spanning the length of the female luer from base to tip. Functional testing confirmed leaking from the side of the female luer. The cause of the damage was not determined.
 
Event Description
The customer reported the hub of the t-connector that was used on an arterial line cracked and the patient lost blood through the crack. There was no patient harm.
 
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Brand NameMINIBORE PRESSURE REMOVABLE IV CONNECTOR
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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7546689
MDR Text Key109360048
Report Number9616066-2018-00611
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,Followup
Report Date 04/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMZ5302
Device Catalogue NumberMZ5302
Other Device ID Number10885403230554
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/22/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/02/2018
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

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