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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SMALLBORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION SMALLBORE EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number C25012
Medical Device Problem Code Fluid/Blood Leak (1250)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/27/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.
 
Event or Problem Description
It was reported that the anti-siphon valve tubing leaked while infusing etoposide.The adult patient reported wetness then on assessment a small amount of sanguineous drainage was noted on the patient's bed sheets.Tubing was replaced and there was no harm to the patient.
 
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Brand Name
SMALLBORE EXTENSION SET
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8496062
Report Number9616066-2019-00987
Device Sequence Number1062177
Product Code FPA
UDI-Device Identifier10885403235610
UDI-Public10885403235610
Combination Product (Y/N)N
Initial Reporter StateNJ
Initial Reporter CountryUS
PMA/510(K) Number
K790108
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 03/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberC25012
Device Catalogue NumberC25012
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date04/09/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
PRI TUBING, THERAPY DATE (B)(6) 2019
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