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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION BLOOD COLLECTION DEVICE W/MALE LUER; BLOOD SET
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CAREFUSION BLOOD COLLECTION DEVICE W/MALE LUER; BLOOD SET Back to Search Results
Model Number MBC6000
Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/04/2016
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
The customer reported that the rubber detached from the needle and stayed in the bottle.There is no report of a leak, nor was any patient harm reported.
 
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Brand Name
BLOOD COLLECTION DEVICE W/MALE LUER
Type of Device
BLOOD SET
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 Key5532864
MDR Text Key41418148
Report Number9616066-2016-00463
Device Sequence Number1
Product Code KST
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other
Type of Report Initial
Report Date 03/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMBC6000
Device Catalogue NumberMBC6000
Was Device Available for Evaluation? No
Date Manufacturer Received03/10/2016
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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