MAUDE Adverse Event Report: CAREFUSION GRAVITY SETS; SET,ADMINISTRATION,INTRAVASCULAR

Model Number	C42007E
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/19/2018
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 surgery department is having issues with the tubing separating, falling on the floor and leaking after being connected to a patient.There was no patient harm.
Event or Problem Description
The customer reported that the surgery department is having issues with the tubing separating, falling on the floor and leaking after being connected to a patient.There was no patient harm.
Additional Manufacturer Narrative
Correction: removed incorrect lot number.The customer's report that the tubing separated was confirmed.Visual inspection showed a separation at the engagement between the set's first male exit luer end and female luer lock.After manually reconnecting the separated components, functional testing and pressure testing resulted in no further separations.The root cause of the customer's report could not identified.
Event or Problem Description
The customer reported that the surgery department is having issues with the tubing separating, falling on the floor and leaking after being connected to a patient.There was no patient harm.

• Brand Name: GRAVITY SETS
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7967824
• Report Number: 9616066-2018-01950
• Device Sequence Number: 1394764
• Product Code: FPA
• UDI-Device Identifier: 10885403235689
• UDI-Public: 10885403235689
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K820278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2018

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: C42007E
• Device Catalogue Number: C42007E
• Device Lot Number: 17103145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/15/2018
• Supplement Report FDA Received Date: 10/24/2018; 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1