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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION CORPORATION BLOOD COLLECTION ASSEMBLY, MALE LUER LOCK
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CAREFUSION CORPORATION BLOOD COLLECTION ASSEMBLY, MALE LUER LOCK Back to Search Results
Model Number MBC6000
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/11/2014
Event Type  malfunction  
Event Description
The customer reported that when the blood tube is withdrawn, often the inside needle that is covered with a rubber stopper dislodges and stays in the blood tube, causing blood splashing.No patient harm or medical intervention was reported.No further patient/event information was provided.
 
Manufacturer Narrative
(b)(4).This report was filed by the manufacturer.The customer complaint could not be confirmed because the affected product was discarded and not returned for failure investigation.The root cause of this failure was not identified.
 
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Brand Name
BLOOD COLLECTION ASSEMBLY, MALE LUER LOCK
Type of Device
NA
Manufacturer (Section D)
CAREFUSION CORPORATION
san diego CA
Manufacturer Contact
michelle bitto
10020 pacific mesa blvd.
san diego, CA 92121
8586173316
MDR Report Key4356014
MDR Text Key5222951
Report Number9616066-2014-01131
Device Sequence Number1
Product Code FMH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative,Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/01/2019
Device Model NumberMBC6000
Device Catalogue NumberMBC6000
Device Lot Number301140212
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/11/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2014
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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