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

Model Number	ME1224
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The set was received as an unexpected return with the customer stating reports of leaking from previous complaints.A leak issue was confirmed based on testing performed on the as-received set sample.The leak was observed at the engagement between the tubing and 4-way parallel connector components.Received were the following used samples- 1) extension set model: me1224, lot #unknown; and 2) three maxzero valves model mz1000-07 lots unknown.No obvious issues or damages were observed with the received samples.Functional testing was performed on the as-received samples by connecting a lab syringe filled with water to one of the maxzero valves connected to one of the set¿s three female luer ports and the fluid was attempted to be pushed through.It was observed that there was a fluid leak at the engagement between one of the three tubing's to the parallel connector component.Fluid was attempted to be pushed through the rest of the ports and a leak was observed at the same engagement.Further inspection under magnification 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
The set was received as an unexpected return with an unknown issue.Although the customer stated: "we have samples to send that are leaking from a previous complaints it is unknown what the product failure is on the unexpected set.''.

• 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: 8825794
• Report Number: 9616066-2019-02093
• Device Sequence Number: 3039664
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/28/2019

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: ME1224
• Device Catalogue Number: ME1224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1