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

Catalog Number	MZ5309
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd maxzero multi-fuse pressure rated extension set with needleless connector was occluded.The following information was provided by the initial reporter, translated from french to english: could you confirm the number of children affected? several children.Could you confirm the impact on patients? temporary consequences (increased procedure or anesthesia time).Commercial reference: (b)(4).Batch no.: 25019127.Date of occurrence: (b)(6) 2025.Description of incident: impossible to inject.
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
Additional information in section b.Investigation result: one mz5309 sample was received in sealed packaging from lot 25019127 for investigation.No connecting product was received to aid the investigation.The customer reported that they observed "no reflux; little reflux; difficult to screw to the kt; clamp hard and damages tubing (see leakage); inability to inject" on several occasions.A visual inspection of the returned samples did not identify any product defects or manufacturing issues which could have caused or contributed to the customer's experience.The sample was then subjected to functional testing by priming and flushing using a 50ml bd plastipak syringe, and no obstruction of flow was observed throughout testing.The details of this feedback were forwarded to the manufacturing site for investigation.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects or quality deviation that could have contributed to the customer¿s experience.A review of the production records for lot 25019127 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Although it was not possible to determine a definitive root cause for the customer's experience, the quality team at the manufacturing site has been informed of this complaint in order to be aware of the reported failure mode during future production of this product.A review of the customer feedback database indicates that complaints of this nature are rare and there is currently no trend for issues of this nature against the mz5309 product.
Event or Problem Description
Could you confirm the number of children affected? several children.Could you confirm the impact on patients? temporary consequences (increased procedure or anesthesia time).

• 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: 22212252
• Report Number: 9616066-2025-01581
• Device Sequence Number: 8262437
• Product Code: FPA
• UDI-Device Identifier: 10885403242083
• UDI-Public: (01)10885403242083(11)250108(17)280108(10)25019127
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

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: MZ5309
• Device Lot Number: 25019127
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 07/11/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown