MAUDE Adverse Event Report: Sistemas Medicos Alaris S.A de C.V. Maxzero; Set, Administration, Intravascular

Catalog Number	MZ1000 CHINA
Medical Device Problem Codes	Leak/Splash (1354); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, maxzero, connection issues, causing leak.The following was provided by the initial reporter: during the procedure to insert an iv cannula on (b)(6) 2026, the nurse connected a clear, cannula-free connector to the patient.The connector did not lock securely, causing fluid leakage.The nurse immediately replaced it with a new clear, cannula-free connector.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Annex f code changed from f26 to f2301.Investigation result: the complaint sample was not available for investigation; however, the customer confirmed that the sample mz1000 china was from lot 25095139.The customer reported that the connector did not lock securely, causing fluid leakage.No further information was available to assist the investigation.The details of the feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 25095139 did not identify any in-process testing failures or quality deviations that may have caused or contributed to a report of this nature.The root cause of the reported experience could not be determined because no sample was received for examination.Without a sample, it was not possible to determine whether a manufacturing defect could have caused or contributed to the reported event.A review of available complaint history for the relevant batch and associated defect code was conducted as part of the investigation.The information reviewed did not change the conclusions reached during the investigation.Complaint data continues to be monitored through established quality system processes, as appropriate.What does this mean for me? based on the information available from the investigation, the root cause of the reported event could not be determined because the complaint sample was not available for examination.Without a sample, it was not possible to conclusively link the feedback to a specific failure mode or determine whether a manufacturing defect could have caused or contributed to the event.What happens next? if you require product replacement or credit consideration, please contact your bd representative or customer care team for assistance.

• Brand Name: Maxzero
• Common Device Name: Set, Administration, Intravascular
• Manufacturer (Section D): Sistemas Medicos Alaris S.A de C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): Sistemas Medicos Alaris S.A de C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50868130
• Report Number: 9616066-2026-02412
• Device Sequence Number: 21505419
• Product Code: FPA
• UDI-Device Identifier: 10885403224782
• UDI-Public: (01)10885403224782
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132413
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: Health Professional
• Device Catalogue Number: MZ1000 CHINA
• Device Lot Number: 25095139
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown