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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxzero multi-fuse extension set with needleless connector had leakage.The following information was provided by the initial reporter: the connection started leaking as soon as the ivf and nahco3 infusion was started.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
One sample was received for quality evaluation.Visual inspection indicates that the luer adapter cracked.With the luer adapter being cracked.Leakage was identified coming from the crack in the luer.The customer complaint of leakage was confirmed.The investigation was forwarded to the manufacturing team and it was determined that the probable root cause was due to an over tightening or use of alcohol or antiseptic on the joining surfaces, and not allowing for the alcohol or antiseptic to dry before connection.This can cause cracks in the material.A device history record review for material# mz9265 and lot# 24119278 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 15nov2024.There were no 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: 22294046
• Report Number: 9616066-2025-01621
• Device Sequence Number: 12827829
• Product Code: FPA
• UDI-Device Identifier: 10885403240775
• UDI-Public: (01)10885403240775(11)241115(17)271115(10)24119278
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/25/2025

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: 24119278
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Supplement Date Received by Manufacturer: 08/25/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown