MAUDE Adverse Event Report: CAREFUSION AS LVP SS BAG 20D 2SS TEX CV; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	10013361T
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Event or Problem Description
The customer reported that the tubing which was infusing etoposide to a patient was noted to be cracked and leaking between the fused texium and tubing.There was no patient harm.
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
The customer reported that the tubing which was infusing etoposide to a patient was noted to be cracked and leaking between the fused texium and tubing.There was no patient harm.
Additional Manufacturer Narrative
Correction: this event was inadvertently submitted under the incorrect fei.Please refer to manufacturer report number 9616066-2019-00897 with the corrected event information.
Event or Problem Description
The customer reported that the tubing which was infusing etoposide to a patient was noted to be cracked and leaking between the fused texium and tubing.There was no patient harm.

• Brand Name: AS LVP SS BAG 20D 2SS TEX CV
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8003372
• Report Number: 2016493-2018-00782
• Device Sequence Number: 10835064
• Product Code: FPA
• UDI-Device Identifier: 10885403223204
• UDI-Public: 10885403223204
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K053049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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 Number: 10013361T
• Device Catalogue Number: 10013361T
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 11/06/2018; 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1