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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION BLOOD COLLECTION DEVICE W/MALE LUER; SYSTEM, BLOOD COLLECTION,VACUUM-ASST
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CAREFUSION BLOOD COLLECTION DEVICE W/MALE LUER; SYSTEM, BLOOD COLLECTION,VACUUM-ASST Back to Search Results
Model Number MBC6010
Device Problem Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/27/2015
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer.No investigation was performed.The root cause of this failure was not identified.
 
Event Description
The customer reported a vacutainer septum became lodged in the rubber stopper of a blood culture bottle.There is no report of leakage or patient harm.
 
Manufacturer Narrative
Correction on initial report.
 
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Brand Name
BLOOD COLLECTION DEVICE W/MALE LUER
Type of Device
SYSTEM, BLOOD COLLECTION,VACUUM-ASST
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 Key4935547
MDR Text Key22866633
Report Number9616066-2015-00922
Device Sequence Number1
Product Code KST
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other
Type of Report Followup
Report Date 07/07/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/23/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMBC6010
Device Catalogue NumberMBC6010
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received04/22/2016
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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