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

Catalog Number	MZ9277
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device history evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd maxzero microbore extension set was leaking the following information was received by the initial reporter with the following verbatim "the cannula connector is crooked and leaking.".
Additional Manufacturer Narrative
No samples were received for investigation of (b)(4), in which the customer has stated: ¿the cannula connector is crooked and leaking.¿ the product in use at the time is reported to be a mz9277 from lot 22049314.No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation, where a review of the production records for lot 22049314 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.It was however also noted that the expiry date of lot 22049314 was apr 2025.A definitive root cause for the customer's experience could not be determined in this instance, however as the product had expired approximately three months prior to the maxzero being clinically used, it is unlikely that a manufacturing defect may have contributed to the customer's experience.In this instance, without the complaint sample to examine it has not been possible to conclusively link this feedback to a specific failure mode; however, a review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the maxzero component in the past 12 months.
Event or Problem Description
No additional information.

• 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: 22301619
• Report Number: 9616066-2025-01628
• Device Sequence Number: 8837812
• Product Code: FPA
• UDI-Device Identifier: 10885403240799
• UDI-Public: (01)10885403240799(11)220422(17)250425(10)22049314
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 07/22/2025

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 Expiration Date: 04/25/2025
• Device Catalogue Number: MZ9277
• Device Lot Number: 22049314
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2025
• Supplement Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown