MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. MAXZERO; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ9267
Medical Device Problem Codes	Leak/Splash (1354); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxzero extension set was separated the following information was received by the initial reporter with the following verbatim it was reported by customer that the twisting part of the luer has come off , including 1 where then the end of the tubing got stuck in the valve and broke off the tubing, requiring them to get a clamp to pull it out and the piece that broke off is the distal end luer lock piece that connects to the patient tubing.
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 was provided.
Additional Manufacturer Narrative
The customer reported the tubing luer broke off, and returned a photo sample of material mz9267, lot 25029192.Upon initial visual examination, the set verified the complaint of broken off female luer.There is no physical sample available for testing.The manufacturing plant could not verify the root cause for the solvent, without the physical sample investigation.The plant did not take any actions to address the failure as the line for material mz9267 was reactivated at a different bd plant, starting 10mar2025.The plant that produced this batch is no longer producing the material number.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.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: MAXZERO
• 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: 22109859
• Report Number: 9616066-2025-01413
• Device Sequence Number: 15272791
• Product Code: FPA
• UDI-Device Identifier: 10885403240720
• UDI-Public: (01)10885403240720(10)25029192
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: MZ9267
• Device Lot Number: 25029192
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/07/2025
• 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