MAUDE Adverse Event Report: CAREFUSION 6.5-IN PRESSURE RATED MINIBORE EXT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	ME5302
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Although requested, patient demographics was not provided.
Event or Problem Description
It was reported that an intravenous lipids (il) infusion was leaking after a new tubing was hung for a night time fluid change.The tubing was then inspected and traced the set all the way down to the patient's side and the it was dry.It was noted that il was infusing through syringe pump.The tubing was disconnected from the patient and the doctor was notified.The infusion was stopped as the pharmacy does not make intravenous lipids at night.The event occurred in neonatal intensive care unit.There was no patient injury.
Additional Manufacturer Narrative
Additional information provided: disregard file (the customer stated that the reported product involved (b)(4) is not the correct product involved in the event and the correct set is a non-bd product).
Event or Problem Description
It was reported that an intravenous lipids (il) infusion was leaking after a new tubing was hung for a night time fluid change.The tubing was then inspected and traced the set all the way down to the patient's side and the it was dry.It was noted that il was infusing through syringe pump.The tubing was disconnected from the patient and the doctor was notified.The infusion was stopped as the pharmacy does not make intravenous lipids at night.The event occurred in neonatal intensive care unit.There was no patient injury.

• Brand Name: 6.5-IN PRESSURE RATED MINIBORE EXT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9588719
• Report Number: 9616066-2020-00148
• Device Sequence Number: 11597500
• Product Code: FPA
• UDI-Device Identifier: 10885403236310
• UDI-Public: 10885403236310
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2019

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 Number: ME5302
• Device Catalogue Number: ME5302
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015,8110,20ML SYRINGE, THERAPY DATE (B)(6) 2019.