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

Catalog Number	MZ9270
Medical Device Problem Codes	Leak/Splash (1354); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxzero multi-fuse extension set with needleless connector was damaged the following information was received by the initial reporter with the following verbatim occurred in june 2024: one filter leaking from the vent hole on the back of the filter.8/2/2024: second filter leaking from the vent hole on the back of the filter.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
The customer reported filter leakage, and returned one used sample of material mz5302, lot unknown.The set was infused with water, and the complaint of leakage was verified from the air vent on the filter.Supplier of filter to investigate the sample further.The supplier investigation found no issue with the filter component.The filter issue potential root cause is related to the end user drugs/solution used.A device history record review could not be performed on material mz9270 because the lot number is unknown.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
No additional information was provided.

• Brand Name: BD MAXZERO MULTI-FUSE EXTENSION SET WITH NEEDLELESS CONNECTOR
• 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: 20319560
• Report Number: 9616066-2024-01389
• Device Sequence Number: 7613401
• Product Code: FPA
• UDI-Device Identifier: 10885403240737
• UDI-Public: (01)10885403240737
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2024

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: MZ9270
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 11/14/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown