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 Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "the bd maxguard extension set with two needleless y-sites (mx9059) leaks at the ports this has happened with multiple sets on different patients." an incomplete date of event of (b)(6) 2019 was provided.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states; "the bd maxguard extension set with two needleless y-sites (mx9059) leaks at the ports.This has happened with multiple sets on different patients".An incomplete date of event of xx-nov-2019 was provided.Although requested, there has been no further patient or event information made available to date.
Additional Manufacturer Narrative
The customer's report of an extension tubing leaking at the injection ports was not confirmed.The set was inspected for kinks, holes/tears in the tubing or damages to the components.No issue was observed.Visual inspection, functional testing, and pressure testing of the received set sample observed no issues.The root cause of the reported extension tubing leaking at the injection ports was unable to be 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: 9417319
• Report Number: 9616066-2019-03565
• Device Sequence Number: 1725382
• Product Code: FPA
• UDI-Device Identifier: 10885403237584
• UDI-Public: 10885403237584
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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: 07/12/2024
• Device Model Number: MX9059
• Device Catalogue Number: MX9059
• Device Lot Number: 19075824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2019
• Supplement Report FDA Received Date: 02/21/2020
• 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: TWO NON-BD ALCOHOL CAPS.
• Patient Age: 50 YR