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	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxzero multi-fuse extension set with needleless connector was separated.The following information was received by the initial reporter with the following verbatim: it was reported by customer that while attempting to disconnect the bifuse from the access device, the bifuse snapped in half closer to the luer access device.A portion of the bifuse tubing remained stuck in the access device and was unable to be removed.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
One sample model mz9265 was returned for investigation.The set was examined for defects and abnormalities.The male luer was broken off and stuck in the connector.No other defects or abnormalities were observed.The customer complaint was verified.However, on the description the most probable cause is the alcohol swab was not fully dried before connecting the sets.Antiseptic device swabs that contain (chlorhexidine gluconate (3.15%) and isopropyl alcohol (70%), leave a slightly sticky residue after drying is complete.The combination of the two component surfaces still being wet when connected, and the chlorhexidine gluconate residue, was observed to bond the two surfaces together during functional testing.This would explain the difficultly with disconnecting the sets and the excessive force of trying to disconnect them causing the male luer to snap.A device history record review could not be performed because a lot number was not provided by the customer.

• 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: 21937910
• Report Number: 9616066-2025-01070
• Device Sequence Number: 17493913
• Product Code: FPA
• UDI-Device Identifier: 10885403240775
• UDI-Public: (01)10885403240775
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2025

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: UNKNOWN
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown