MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ5309
Medical Device Problem Code	Reflux within Device (1522)
Health Effect - Clinical Codes	Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
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
It was reported that the bd maxzero multi-fuse pressure rated extension set with needleless connector had blood backflow.The following information was provided by the initial reporter, translated from french to english: could you confirm the impact on patients? temporary consequences (increased procedure or anesthesia time).Commercial reference: mz5309 batch no.: 25019127 date of occurrence:(b)(6) 2025 description of incident: no reflux; little reflux.
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).
Additional Manufacturer Narrative
Additional information 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.Additionally, when subjected to pressure testing; no leakage was observed from the infusion set 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.Please note the maxzero is not a back check valve and under certain circumstances it is possible for blood to back flow into the maxzero; such a phenomenon can occur if the patient has high blood pressure.As stated in the directions for use "flush the maxzero after each use with normal saline or in accordance with facility protocol." and "failure to properly prime the device can result in reflux".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.

• Brand Name: BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR(S)
• 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: 22212211
• Report Number: 9616066-2025-01583
• Device Sequence Number: 12799155
• 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
• 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: 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