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

Catalog Number	MZ9294
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxzero extension set was leaking the following information was received by the initial reporter with the following verbatim it was reported by customer that leakage around the sealed circular filter.
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
Mz9294/ 24039293.It was reported that bd maxzero extension set was leaking.Incorrect material number submitted.
Additional Manufacturer Narrative
Mdr was submitted with incorrect material number.Material number updated in b and d tab.One sample was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was flushed with water and a leak was seen coming from the filter vent.Fluid would not flow through the entire set.Visual inspection under the microscope showed signs of excess solvent at the male luer.The customer complaint was verified and a quality notification was sent to the manufacturer.Occlusion between tubing and male luer could be related to excess of solvent due to an incorrect solvent application by the assembler for not follow correctly the work instructions or issues with the solvent dispenser.No additional actions were taken since reported sku was deactivated in hermosillo site, tj site will reactive production of this sku.A device history record review 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.; 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: 23069295
• Report Number: 9616066-2025-02786
• Device Sequence Number: 21343296
• Product Code: FPA
• UDI-Device Identifier: 10885403417900
• UDI-Public: (01)10885403417900(17)270318(10)24039293
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: MZ9294
• Device Lot Number: 24039293
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown