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	MZ5303
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/15/2025
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(s) had leakage.The following information was provided by the initial reporter: during the injection of medication, the product leaked at the luer lock.The extension was cut and a new catheter was inserted.Additional information received from the customer: could you confirm how the defect was identified? the defect was identified when sodium chloride was injected into the patient, at which point the department became aware of the leak.Could you confirm when the defect was identified, during priming or during infusion? if it occurred during infusion, at what point? during infusion, at the time of injection.Could you confirm whether there is any visible damage to the device, such as cracks, chips or deformation of the piston? upon receipt of the device, we noticed that the luer lock was ¿misaligned¿.Could you confirm what substance was being infused at the time of the incident? i believe it was sodium chloride.Did the patient suffer any harm? the patient had to be reinfused.Was the user present and able to intervene at the time of the incident? the user was present and intervened directly.Was there an external leak? yes, at the luer lock.Was there any under-infusion? i don't think so.
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.
Additional Manufacturer Narrative
Investigation result: one mz5303 sample was received for investigation in opened packaging from lot 24059476.The male luer was severed from the received set and not returned; some residual fluid was present in the set.The customer reported that "during the injection of a medication, the product leaked from the luer lock".As part of the investigation, the customer provided a photograph and video of the affected sample.Analysis of the video confirmed the customer's experience as leakage could be seen at the maxzero tubing joint.Additional information provided by the customer also noted that the maxzero was "misaligned" on the tubing, and that leakage occurred at the beginning of infusion.Visual inspection of the returned sample confirmed the customer's description of the maxzero being misaligned with the rest of the extension set.Furthermore when subjected to leakage testing, leakage was confirmed at the maxzero joint to the female luer.The details of this feedback were forwarded to the manufacturing site for investigation.Their analysis confirmed that the leakage is likely to have been caused by the maxzero not being correctly screwed onto the female luer of the affected joint during manufacture.This is a manually performed assembly step and is likely to have occurred due to human error.A review of the production records for lot 24059476 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Please note, since the manufacture of the reported lot, the product has been transferred to an alternative manufacturing site; however the quality team will continue to monitor the incoming feedback and remain vigilant to reports of this nature.A review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the mz5303 set in the past 12 months.

• 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: 22606066
• Report Number: 9616066-2025-02131
• Device Sequence Number: 15844038
• Product Code: FPA
• UDI-Device Identifier: 10885403230561
• UDI-Public: (01)10885403230561(11)240528(17)270528(10)24059476
• 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): 09/02/2025

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: MZ5303
• Device Lot Number: 24059476
• 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: 06/30/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown