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

Catalog Number	MZ9281
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxzero extension set was cracked.The following information was received by the initial reporter with the following verbatim it was reported by a customer that the luer collar was cracking.
Event or Problem Description
Samples investigation.
Additional Manufacturer Narrative
Description of event it was reported by a customer that the luer collar was cracking.Investigation results the customer returned 3 samples of trifuse material mz9281, lot 25085808, this investigation will be for 1 individual sample.Upon initial visual examination, the set verified the report of component damage, and the male luer spin collar was cracked and broken.The samples were sent for further investigation to the supplier of the component.Device / batch history records (dhr/bhr) for batch 25085808 were reviewed to determine if there was a potential manufacturing or material issue related to the reported complaint.Review of in-process and final inspection records confirmed that all required inspections were completed and met established acceptance criteria.The supplier of the component confirmed the failure, but was unable to define the root cause or trace it to their process.Due to the ongoing issue with the mz9283 quadfuse and mz9281 trifuse sets, the investigation has been escalated to a cross-functional team, and a funded project has been opened.The project will further investigate the issue.

• Brand Name: BD MAXZERO EXTENSION SET
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25231359
• Report Number: 9616066-2026-01323
• Device Sequence Number: 12072002
• Product Code: FPA
• UDI-Device Identifier: 10885403230646
• UDI-Public: (01)10885403230646(17)280826(10)25085808
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: MZ9281
• Device Lot Number: 25085808
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown