MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. De C.V. BD MaxZero Needleless Connector; Intravascular administration set

Catalog Number	MZ5304
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxzero needless connector had flow issues the following information was received by the initial reporter with the following verbatim no specific lot #s have been provided because it is a widely perceived issue.Lack of securement causes leaking, air in line, hemolysis, and difficulty aspirating/flushing.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD MaxZero Needleless Connector
• Common Device Name: Intravascular administration set
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. De C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. De C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50577642
• Report Number: 9616066-2026-02205
• Device Sequence Number: 9872305
• Product Code: FPA
• UDI-Device Identifier: 10885403230578
• UDI-Public: (01)10885403230578(11)260528(17)290527(10)26056032
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• 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
• Report Date (Section B): 09/01/2026

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: MZ5304
• Device Lot Number: 26056032
• 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: Not provided
• Initial Report FDA Received Date: 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown