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

Catalog Number	MZ5307
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date of event is unknown; bd awareness date used.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 had leakage.The following information was provided by the initial reporter, translated from spanish to english: the emergency department has reported the following incident regarding item code 1032058, 18 cm pressure resistor extension cord, mz5307 (without packaging, 1 unit): "it has a leak in the area where the anti-reflux cap is located." since this problem is not associated with a specific batch and has occurred several times, we recommend exploring the possibility of obtaining a safer and more reliable alternative on the market.Additional information received from the customer: 1) the lot number of the venous extender is 25029025.2) this incident has occurred more than 10 times, resulting in leakage of administered medications.3) during today, 3/11/2025, this problem has occurred 3 times only today.
Additional Manufacturer Narrative
Investigation result: no mz5307 sample was available for investigation; the customer reported that the affected sample was from lot 25029025 and that "there is a leak in the area where the anti-reflux cap is located.¿ as part of the investigation, the customer provided a video of the affected sample; analysis confirmed that leakage could be observed between the maxzero and the syringe, however no obvious damage was visible which may have contributed to the customer's experience.The details of this feedback were forwarded to the manufacturing site for investigation.Previous investigations have been unable to determine a potential root cause for the customer's experience; no obvious manufacturing defects or potential manufacturing contributors were identified which may have resulted in the observed damage.A review of the production records for lot 25029025 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Although a definitive root cause could not be determined in this instance, previous investigations have confirmed similar damage can be caused or contributed to by a combination of different factors, including prolonged use of substances that are aggressive to plastics, over-torque of the component during connection with the male luer, or use of a male luer that is not compliant to iso standards.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 mz5307 product.
Event or Problem Description
No additional information.

• Brand Name: BD MAXZERO MULTI-FUSE PRESSURE RATED EXTENSION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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 ; 8473935694
• MDR Report Key: 23627924
• Report Number: 9616066-2025-03561
• Device Sequence Number: 9336891
• Product Code: FPA
• UDI-Device Identifier: 10885403230608
• UDI-Public: (01)10885403230608
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: MZ5307
• Device Lot Number: 25029025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/23/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown