MAUDE Adverse Event Report: CAREFUSION MAXGUARD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	ME1224
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.
Event or Problem Description
It was reported that the iv fluid was leaking out at junction of the trifuse extension set.The event occurred in the operating room (or).There was no patient harm and the event did not cause delay in patient therapy.
Event or Problem Description
It was reported that the iv fluid was leaking out at the junction of the tri-fuse extension set.The event occurred in the operating room (or).It was confirmed that there was no patient harm and the event did not cause any delay in patient therapy.
Additional Manufacturer Narrative
Supplemental created to remove comment from initial report- correction to h10: ¿.Large bubble in the silicone segment was confirmed by visual inspection", was placed in error.
Additional Manufacturer Narrative
The customer¿s report of a leak at the junction of the trifuse extension set was confirmed based on functional inspection.Report that the iv tubing had a large bubble in the silicone segment was confirmed by visual inspection.The leak was observed at the engagement between one of the three tubing's to the inlet of the parallel connector components.The sample was inspected for kinks, holes/tears in the tubing or damages to the components.A fluid filled lab syringe was used and functional testing was performed by pushing the fluid through.Additional pressure testing was performed and the leak was observed at the same engagement.Further inspection noted no issues with any of the tubing depths within the parallel connector.The root cause was identified as a sink condition in the parallel connector component (supplier issue).
Event or Problem Description
It was reported that the iv fluid was leaking out at the junction of the tri-fuse extension set.The event occurred in the operating room (or).It was confirmed that there was no patient harm and the event did not cause any delay in patient therapy.

• Brand Name: MAXGUARD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9315053
• Report Number: 9616066-2019-03216
• Device Sequence Number: 2509523
• Product Code: FPA
• UDI-Device Identifier: 10885403236112
• UDI-Public: 10885403236112
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/18/2019

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 Expiration Date: 09/03/2023
• Device Model Number: ME1224
• Device Catalogue Number: ME1224
• Device Lot Number: 18095129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 01/17/2020; 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1