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

Model Number	42504E
Medical Device Problem Code	Disconnection (1171)
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 that the tubing disconnected at the stopcock during patient use.The patient's blood start to fill the tubing, but there was no patient harm.
Additional Manufacturer Narrative
The customer¿s report of disconnection of the tubing at the stopcock was confirmed.Visual inspection of noted the set was separated from its male luer.The luer remained locked to the top end of the manifold.Examination under magnification of the separated tubing revealed only slight evidence of bonding solvent.No additional discernible signs of damage or abnormalities were observed.Functional testing was deemed unnecessary due to separation.The root cause of the separation was an insufficient bonding solvent application during assembly of the tubing set.
Event or Problem Description
The customer reported that the tubing disconnected at the stopcock during patient use.The patient's blood started to fill the tubing, but there was no patient harm.
Event or Problem Description
The customer reported that the tubing disconnected at the stopcock during patient use.The patient's blood started to fill the tubing, but there was no patient harm.

• Brand Name: GRAVITY SET
• Common Device Name: SET,ADMINISTRATOIN,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7883924
• Report Number: 9616066-2018-01731
• Device Sequence Number: 1927971
• Product Code: FPA
• UDI-Device Identifier: 10885403235405
• UDI-Public: 10885403235405
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 08/31/2018

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: 01/12/2021
• Device Model Number: 42504E
• Device Catalogue Number: 42504E
• Device Lot Number: 18015863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/17/2018
• Supplement Report FDA Received Date: 12/28/2018; 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1