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

Catalog Number	MZ9294
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
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(s) leaked.The following information was provided by the initial reporter: we had another mazzero bifuse malfunction and also a trifuse.Trifuse was leaking at same filter location as bifuses.
Additional Manufacturer Narrative
One sample was returned for investigation under this complaint.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was flushed with water and a leakage was confirmed coming from the bond between the tubing and filter outlet port.The customer complaint was verified.From the manufacturer's investigation, the potential root cause of leak between tubing and pediatric filter could be related to an incorrect solvent application by the assembler or issues with the solvent dispenser.A device history record review was performed.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(S)
• 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: 21615626
• Report Number: 9616066-2025-00528
• Device Sequence Number: 8515580
• Product Code: FPA
• UDI-Device Identifier: 10885403417900
• UDI-Public: (01)10885403417900(11)240318(17)270318(10)24039293
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 04/21/2025

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: MZ9294
• Device Lot Number: 24039293
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2025
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 03/16/2025
• Supplement Report FDA Received Date: 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown