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

Catalog Number	MZ9276
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
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 leaking the following information was received by the initial reporter with the following verbatim it was reported by the customer that maxzero trifuse with lipid filter and med line leaking at lipid filter.
Additional Manufacturer Narrative
Investigation summary: one used mz9276 tri-fuse filter extension set was received and tested by our quality team with the customer's complaint of leakage.The set was visually inspected and no abnormalities were found.The set was then primed and infused with saline solution and the leak at the male luer end of filter where tubing is inserted into filter during assembly.The tubing-filter junction was then analyzed under high power digital microscope and there appeared to be a lack of solvent (glue) applied.A light tension pull was then applied to the set and a separation was forced.The tubing was reexamined under microscope and the solvent was found to only be applied to half of the tubing radially.The complaint of leakage has been verified and the root cause is due to improper application of solvent by operator during the assembly of the tubing to filter junction.No additional actions have been taken due to the plant no longer producing this product.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.
Event or Problem Description
Sample.

• 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: 23528805
• Report Number: 9616066-2025-03440
• Device Sequence Number: 13028070
• Product Code: FPA
• UDI-Device Identifier: 10885403240843
• UDI-Public: (01)10885403240843(10)24109086
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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,Followup
• Report Date (Section B): 01/27/2026

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: MZ9276
• Device Lot Number: 24109086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown