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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION BLOOD SETS
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CAREFUSION BLOOD SETS Back to Search Results
Model Number 10062818
Device Problems Material Fragmentation (1261); Sticking (1597); Failure to Disconnect (2541)
Patient Problem Needle Stick/Puncture (2462)
Event Type  Injury  
Manufacturer Narrative
No product will be returned per customer. The customer complaint could not be confirmed because the product was not sequestered for failure investigation. The root cause of this failure was not identified.
 
Event Description
The customer reported that at the end of a stem cell blood transfusion, they were unable to disconnect the blood tubing from the picc line. When they attempted to use clamps to remove the tubing, the tubing broke and the broken tip became stuck in the picc line. The picc was replaced.
 
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Brand NameBLOOD SETS
Type of DeviceBLOOD 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 Key5666622
MDR Text Key45508862
Report Number9616066-2016-00697
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K894842
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 04/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10062818
Device Catalogue Number10062818
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2016
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 Treatment Data
Date Received: 05/19/2016 Patient Sequence Number: 1
Treatment
PICC LINE, THERAPY DATE UNK
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