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

Model Number	MX9059
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 extension set leaked at connection to an unspecified mating device during use on a patient.Although there was a slight delay in treatment while the device was stopped and restarted, as well as fluids that leaked onto the patient's clothing, there were no adverse effects caused to the patient from the event.
Event or Problem Description
It was reported that the extension set leaked at connection to an unspecified mating device during use on a patient.Although there was a slight delay in treatment while the device was stopped and restarted, as well as fluids that leaked onto the patient's clothing, there were no adverse effects caused to the patient from the event.
Additional Manufacturer Narrative
The customer¿s report that the set leaked was confirmed.However, the leak was observed from the silicone segment of the primary set and not at the extension set connection as reported by the customer.Functional and pressure testing found no leaks were observed from the connection of the two mating components (extension set to primary set) as reported by the customer.Testing of the primary set's silicone segment component observed there was a tear, measured as approximately 0.001 inches in length, directly below the upper fitment component.A leak was observed from the tear during testing.The observed leak was due to a tear on the silicone segment component.The root cause of the tear was not identified.

• 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: 9913482
• Report Number: 9616066-2020-01150
• Device Sequence Number: 3257448
• Product Code: FPA
• UDI-Device Identifier: 10885403237584
• UDI-Public: 10885403237584
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: MX9059
• Device Catalogue Number: MX9059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/01/2020
• Supplement Report FDA Received Date: 07/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8015, 2426-0007, 8100, THERAPY DATE UNKNOWN