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

Model Number	C42010E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 four events where the iv sets came apart, some during administration.No patient harm was reported.This is the file for one event.
Event or Problem Description
The customer reported four events where the iv sets came apart, some during administration.No patient harm was reported.This is the file for one event.
Additional Manufacturer Narrative
The customer¿s report of iv sets coming apart was confirmed.Visual inspection showed no anomalies.Gentle tugging of the tubing resulted in a separation of the lower portion of the tubing from the stopcock.The root cause of the failure was determined to be failure to tighten the stopcock connections prior to use.
Event or Problem Description
The customer reported four events where the iv sets came apart, some during administration.No patient harm was reported.This is the file for one event.

• Brand Name: GRAVITY SET
• Common Device Name: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7867054
• Report Number: 9616066-2018-01652
• Device Sequence Number: 16478219
• Product Code: FPA
• UDI-Device Identifier: 10885403230059
• UDI-Public: 10885403230059
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 08/21/2018

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 Expiration Date: 07/02/2021
• Device Model Number: C42010E
• Device Catalogue Number: C42010E
• Device Lot Number: 18075002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/11/2018
• Supplement Report FDA Received Date: 09/20/2018; 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1