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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION NEUTRACLEAR EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION NEUTRACLEAR EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number PB-NC5302
Device Problems Occlusion Within Device (1423); Material Deformation (2976)
Patient Problems Therapeutic Response, Increased (2272); Underdose (2542)
Event Date 03/26/2018
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: pressure injector isovue-370 iopamidol injection 76%; therapy date: (b)(6) 2018. The affected product has been received and the evaluation is pending. A follow up report will be submitted once the evaluation is completed.
 
Event Description
The customer reported that while performing a cta of the pulmonary arteries with a non-bd power injector it pressured out at 4 ml/second while injecting isovue 370 (which ranges from 80 ml - 100 ml based on patient weight and procedure) along with a 25 ml ns flush. The slide clamp on the tubing caused the tubing to remain crimped after releasing it which prevented a full dose of the medication from being delivered to the patient. This caused the patient to receive additional medication to complete the procedure and an additional ct scan. There was no lasting harm.
 
Manufacturer Narrative
The customer¿s report of a crimp in the tubing was confirmed but was determined to be unrelated to the power injection issue. The report of increased pressure (restricted flow) was confirmed. Visual inspection showed a kink/crimp in the tubing approximately 4. 2mm from the male luer. Functional testing showed that the high pressure is due to an incompatibility between the concomitant non-bd pressure injector syringe and tubing and the neutraclear valve. The male luers of the non-bd syringe and pressure injector tubing have a section with an internal diameter of 1. 35mm. The neutraclear directions for use state that the neutraclear needle-free connector is compatible with all iso 594 certified luers with an internal diameter larger than 1. 5mm. The concomitant device male luer is incompatible and caused restricted flow through the neutraclear. The kink/crimp in the tubing due to the engagement of the slide clamp is normal and does not lead to a loss of flow or a rise in pressure. The root cause of the restricted flow is an incompatibility between the neutraclear connector and the male luers of the mating products.
 
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Brand NameNEUTRACLEAR EXTENSION SET
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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7429209
MDR Text Key105417075
Report Number9616066-2018-00445
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171118
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPB-NC5302
Device Catalogue NumberPB-NC5302
Device Lot Number17125-T
Other Device ID Number10885403425479
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/03/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
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: 04/13/2018 Patient Sequence Number: 1
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