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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2025
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 bd maxzero multi-fuse extension set with needleless connector was leaking the following information was received by the initial reporter with the following verbatim it was reported by the customer that had 3 more incident similar to this issue, where tpn filter was leaking last weekend.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of leakage and flow issues - fluid blockage could not be verified due to the product not being returned for failure investigation.A device history record review for material# mz9270 and lot# 24039216 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 12mar2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
Event or Problem Description
Material#: mz9270 & batch#: 24039216.It was reported by the customer that had 3 more incident similar to this issue, where tpn filter was leaking last weekend.Verbatim: we had 3 more incident similar to this issue, where tpn filter was leaking last weekend.It is from same lot#24039216.We don't have samples this time unfortunately.Additional info received on 2feb2025.Hi, sorry what do you mean by occurrence? on one patient there was both the leaking found on the tpn filter, as well as when they then were priming a new one, it was unable to flush through the tpn filter port.Then on the second patient, it was found leaking at the tpn filter.

• 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: 21294729
• Report Number: 9616066-2025-00119
• Device Sequence Number: 9198873
• Product Code: FPA
• UDI-Device Identifier: 10885403240737
• UDI-Public: (01)10885403240737(11)240312(17)270312(10)24039216
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 03/11/2025

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: MZ9270
• Device Lot Number: 24039216
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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