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

Catalog Number	MZ9313
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
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 occluded.The following information was received by the initial reporter with the following verbatim it was reported by the customer that all 3 lumens of bd maxzero tri-fuse extension (ref mz9313), one lumen completely occluded and will not flush.Attempted multiple new sets, all had one lumen occluded and unable to flush.
Additional Manufacturer Narrative
2 samples were received and tested by our quality team with the customer's complaint of occlusion.The sets were tested by injecting saline solution via 20ml syringe and the customer's complaint of occlusion was immediately verified.3 max zero ends of one trifuse set and 2 of the other were occluded when an attempt to inject saline was made.The female luer ends were inspected under high power digital microscope and the female luer ends were found to have an excess of solvent applied by operator during assembly of set.This is the root cause.A quality notification has been initiated and the personnel in charge of solvent application have been further trained to eliminate further occurrences of this issue.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.
Event or Problem Description
Samples.

• 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: 23369689
• Report Number: 9616066-2025-03239
• Device Sequence Number: 9931553
• Product Code: FPA
• UDI-Device Identifier: 10885403471292
• UDI-Public: (01)10885403471292(17)271206(10)24129130
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 01/20/2026

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: MZ9313
• Device Lot Number: 24129130
• 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: 09/30/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown