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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION NEUTRACLEAR NEEDLE-FREE CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION NEUTRACLEAR NEEDLE-FREE CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number EL-NC1001
Device Problems Break (1069); Difficult to Remove (1528); Sticking (1597); Failure to Disconnect (2541)
Patient Problems Needle Stick/Puncture (2462); No Known Impact Or Consequence To Patient (2692)
Event Date 05/05/2018
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 neutraclear connector broke into several pieces when disconnecting from the medication line on a central venous pressure line (cvp). When the connector broke, it left a piece of the connector stuck to the cvp line. The rn was required to prime a new central venous line and the physician replaced the cv line in order to be able to infuse the ordered fluids. A new tubing set was primed and attached to the patient to complete the medication drip. There was no patient harm.
 
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Brand NameNEUTRACLEAR NEEDLE-FREE CONNECTOR
Type of DeviceSET, ADMINISTRATION, 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 Key7567331
MDR Text Key110028346
Report Number9616066-2018-00628
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial
Report Date 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberEL-NC1001
Device Catalogue NumberEL-NC1001
Other Device ID Number10885403463907
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2018
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: 06/04/2018 Patient Sequence Number: 1
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