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	MZ9265
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
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 the bd maxzero multi-fuse extension set with needleless connector was occluded.The following information was provided by the initial reporter: product mz9265 failed to prime or allow fluid flow through the maxzero on two different bi-fuse extension sets.The set with the labels "epinephrine" was used in the pediatric icu and the other set was used in the oncology unit.
Additional Manufacturer Narrative
It was reported by the customer that product mz9265 failed to prime or allow fluid flow through the maxzero on two different bi-fuse extension sets.Two samples of item mz9265 were submitted for quality evaluation.There was no clear visible damages or abnormalities.A fluid flush was then attempted on the samples provided and there was no fluid flow for each of the samples.Further investigation by checking the sample under magnification and an occlusion in the fluid line was identified.This type of occlusion can cause flow issues.The customer complaint of flow issues - fluid blockage was confirmed.The investigation was forwarded to manufacturing for root cause analysis.After the investigation, the possible root cause of the occlusion between the tubing and the adapter could be related to an incorrect solvent application by the assembler or issues with the solvent dispenser.Additionally, the affected sample may have gone undetected due to a missed occlusion test or equipment failure.No corrective actions were taken because the product will not longer be manufactured at the location the sample provided was produced at.We will continue to track and trend the issue and if any negative trends are observed, proper actions will be conducted to address the issue.A device history record review for model mz9266lot number 25019323 was performed.There is one quality notifications issued for the failure mode reported by the customer during the production build of this set.

• 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: 22628030
• Report Number: 9616066-2025-02139
• Device Sequence Number: 9002507
• Product Code: FPA
• UDI-Device Identifier: 10885403240775
• UDI-Public: (01)10885403240775(11)250116(17)280116(10)25019323
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2025

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: MZ9265
• Device Lot Number: 25019323
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 09/04/2025
• Initial Report FDA Received Date: 07/28/2025
• Supplement Report FDA Received Date: 09/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown