MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9226
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxzero multi-fuse extension set with needleless connector occluded the following information was received by the initial reporter with the following verbatim iv pump beeping downstream occlusion intermittently about every 15 to 20 minutes.Changed pumps and checked clamps multiple times.When inspecting syringe it was still at 49ml meaning the patient had not received the medication in about 2 hours after disconnected and changing the tubing out the issue was resolved i attempted to flush through the tubing and was unable to get anything through.The tubing used was the bd max xero filtered microtubing with a lot number 244079130 bbraun alarming downstream.Occlusion with bd maxzero filtered microtubing tubing changed and able to infuse.
Additional Manufacturer Narrative
A2.Patient¿s birthday was not provided, 01-jan-xxxx was used based on age of patient if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
It was reported by the customer that; iv pump beeping downstream occlusion intermittently about every 15 to 20 minutes.Changed pumps and checked clamps multiple times.When inspecting syringe it was still at 49ml meaning the patient had not received the medication.One sample was received for quality investigation.Visual examination was conducted and no damages or abnormalities were identified.The extension set was then primed with water and leak was immediately identified.Further examination, under magnification, indicates that the filter body is separated in half allowing for leakage past the filter body.The customer complaint complete blockage was not verified, however, the filter component is damaged and leaks past the filter body.The investigation has been forwarded to the supplier group for determination of root cause.The supplier conducted a production review and did not identify any issues with the assembly process or find any further issues with the production batch.Due to the lack of information being provided on the medication used and duration of use.A root cause could not be established for the issue.A device history record review for material# mz9226 and lot# 24079130 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 03jul2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH 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
• 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: 21767144
• Report Number: 9616066-2025-00752
• Device Sequence Number: 15606206
• Product Code: FPA
• UDI-Device Identifier: 10885403240621
• UDI-Public: (01)10885403240621(10)244079130
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 07/28/2025

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: MZ9226
• Device Lot Number: 244079130
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male