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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MICROBORE EXTENSION SET SET, EXTENSION, INTRAVASCULAR

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CAREFUSION MICROBORE EXTENSION SET SET, EXTENSION, INTRAVASCULAR Back to Search Results
Model Number 30914
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Information (3190)
Event Date 04/02/2016
Event Type  Injury  
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 clinician noted air in the 'blue iv filter' of the extension set when she was connecting the new iv tpn line. The clinician attempted to draw out the air bubble with a syringe without success. The rn discovered the extension set 'could not draw at all' which resulted in the uvc being discontinued and a new uvc line inserted.
 
Manufacturer Narrative
Concomitant medical products: non-bd stand-alone filter; therapy date (b)(6) 2016. The customer¿s report of an air in the line was confirmed. Upon visual inspection, it was noted that the female luer had a hairline crack. There were no scratches on the exterior of the female luer, indicating that no external force had been applied to the female luer. No defects were found on the rest of the set. During functional testing the set began to leak at the female luer crack. Dimensional testing was performed and the non-bd connector was within specification. The root cause of the customer¿s report of a leak was identified as the cracked female luer. The source of the crack is unknown.
 
Event Description
The rn discovered the extension set ¿could not draw at all¿ which resulted in the uvc being discontinued and a new line was started.
 
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Brand NameMICROBORE EXTENSION SET
Type of DeviceSET, EXTENSION, 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 Key5615067
MDR Text Key43887964
Report Number9616066-2016-00584
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 04/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number30914
Device Catalogue Number30914
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2016
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

Patient Treatment Data
Date Received: 04/28/2016 Patient Sequence Number: 1
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