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	MZ9279
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxzero multi-fuse extension set with needleless connector had separated.The following information was provided by the initial reporter: two incidents where the luer lock collar has detached on the end patient end of the dual lumen extension set.Additional information received from the customer: please confirm how the fault was identified? on attempt to remove extension set from bung.Please confirm when the fault was identified during priming or during infusion? if during infusion, how long into the infusion? unknown but assume at least 24hrs.Please confirm the infusion set-up ¿ gravity or pump, height of infusion line, entry point to patient, infusion rate and pressure, infusion line set-up (other extensions or accessories) etc? all our infusions are pump.Couldn¿t tell you details as has happened multiple times.I think mostly with smof (at least most recent one i can see smof in the line).Please confirm the make and model of the connecting product(s)? vygon picc lines mostly.Fresenius kabi infusion pumps.Please confirm if there is any visible damage on the set ¿ such as cracks, flashes or deformation? not that i could see.Please confirm what substance was being infused during the time of the event? again, number of incidents and could not be sure.Smof on most recent (along with tpn).Was there any patient harm? removed bung from central line which is extra clabsi risk.Was there an under infusion? don¿t think so.
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
No additional information.
Additional Manufacturer Narrative
Two mz9279 samples were received for investigation; one was received without packaging and had some residual fluid inside; the other was received in opened packaging from lot: 24129140.The customer reported "two incidents where the luer lock collar has detached on the end patient end of the dual lumen extension set." additional information confirmed that the issue was identified "on attempt to remove extension set from bung".Upon inspection, it was confirmed that the male luer rotating collar was of the retractable design.Functional testing was conducted by connecting the male luer to various female luers from bd stock.No connection issues were observed, and the connections remained secure throughout testing.However, it was noted that the collar of the male luer could be pulled back beyond the luer component of the extension set, confirming the customer's experience.This feedback was forwarded to the manufacturing site for further investigation.They confirmed that the retention ridge on the male luer was incomplete, which resulted in the male luer collar being able to eb retracted off of the male luer component.A definitive root cause for the observed damaged could not be determined, and it was not possible to determine if a manufacturing defect may have contributed to the customer's experience.A review of the production records for lot: 24129140 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Although it was not possible to determine a definitive root cause for the customer's experience, the quality team at the manufacturing site as well as the supplier of the male luer component have been notified of this feedback for further investigation.A review of the customer feedback database indicates that this is a rare occurrence with this customer being the only customer to provide this type of feedback against the mz9279 product in the past 12 months.

• 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: 22482501
• Report Number: 9616066-2025-01944
• Device Sequence Number: 8554481
• Product Code: FPA
• UDI-Device Identifier: 10885403230622
• UDI-Public: (01)10885403230622(11)241207(17)271207(10)24129140
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: MZ9279
• Device Lot Number: 24129140
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 09/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown