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	MZ9226
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 bd maxzero multi-fuse extension set with needleless connector was leaking the following information was received by the initial reporter with the following verbatim.Leaking seen on tubing on side of filter distal to the patient connection.
Additional Manufacturer Narrative
The customer reported leakage in a mz9226, lot unknown.Upon initial visual examination, the set had no defects or abnormalities.The set was infused with water from a syringe, and the complaint of leakage was verified.The set was leaking from the outlet of the filter.The tubing/filter connection was examined under a microscope, and shallow insertion depth was found with the tubing.The manufacturing site is working on the root cause through a funded project to ensure that the risk of recurrence for the issue is addressed.A quality alert was generated 07nov2024 to communicate the failure and reinforce the correct method of joining the components (tubing/pediatric filter).The issue is a high priority for bd quality.
Event or Problem Description
Material #: mz9226.Batch#: unknown (24059449).It was reported by customer that leaking seen on tubing on side of filter distal to the patient connection.Verbatim: complaint received via email(s) attached.Leaking seen on tubing on side of filter distal to the patient connection.

• 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: 20569390
• Report Number: 9616066-2024-01567
• Device Sequence Number: 12645331
• Product Code: FPA
• UDI-Device Identifier: 10885403240621
• UDI-Public: (01)10885403240621
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/19/2024

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: MZ9226
• Device Lot Number: UNKNOWN
• 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: 10/02/2024
• Supplement Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 12/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown