MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD MAXZERO EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZX5306
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	08/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxzero extension set had leakage.The following information was provided by the initial reporter: when flushing the line the extension set leaked from beneath the white cap on the extension set.
Additional Manufacturer Narrative
E.1.Address was not located, and il was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
One photo was submitted for quality evaluation.Investigation of the photo could not verify the leak location on the y-site.The customer complaint of leakage could not be confirmed.Due to the failure not being clear from the photo received a root cause analysis could not be conducted.A device history record review for model mzx5306 lot number 25045731 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD MAXZERO EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23044605
• Report Number: 9616066-2025-02760
• Device Sequence Number: 9832479
• Product Code: FPA
• UDI-Device Identifier: 10885403463792
• UDI-Public: (01)10885403463792(17)280428(10)25045731
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K171957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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: Other
• Device Catalogue Number: MZX5306
• Device Lot Number: 25045731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown