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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION PRIMARY TUBING SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION PRIMARY TUBING SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number PRI TUBING
Device Problems Fluid Leak (1250); Material Separation (1562)
Patient Problem Eye Injury (1845)
Event Date 10/13/2018
Event Type  Injury  
Manufacturer Narrative
No product will be returned. The customer¿s complaint could not be confirmed because the product will not be returned for failure investigation. The root cause of this failure was not identified.
 
Event Description
It was reported that the tubing separated at pump segment while attempting to insert the safety clamp back into the pump after the clinician flicked the set to remove the air bubbles. The unspecified fluid splashed onto the clinician's right eye. The tubing was immediately clamped to avoid further leak and asked another staff to replace the tubing. The clinician's eye was cleansed with tap water and received saline irrigation for about thirty seconds as the tap water did not help with the burning discomfort. The clinician was sent to the emergency department (ed), ocular movements and visual acuity were checked. No further inflammation noted on the right eye and the clinician was discharged from the ed and returned to the patient care unit. The event occurred in adult bone marrow transplant unit (bmt). Although requested, additional information was not provided.
 
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Brand NamePRIMARY TUBING 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 Key9836803
MDR Text Key184481949
Report Number9616066-2020-00848
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNKNOWN
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 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
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: 03/16/2020 Patient Sequence Number: 1
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