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

Catalog Number	MZ9283
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
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 the bd maxzero minibore quad-fuse extension set was cracked.The following information was provided by the initial reporter: various bd extension sets ¿cracking¿, despite past education efforts.Trifuse and quadfuse microbore extension sets.There have been several products that have broken.Many days involved.Unsure what the lot numbers are.Packages get thrown out.This has been a problem since we received the product so it would span over several lot numbers.We are concerned that there is an increased risk of bloodstream infection.Additionally, when they crack it can be a choking hazard for pediatric patients who are touching their central line or piv.
Event or Problem Description
Samples investigation.
Additional Manufacturer Narrative
Description of event it was reported by customer that bd extension sets ¿cracking¿.Investigation results the customer reported sets are cracking, and returned a bolus of samples under (b)(4), which were spread out among several investigations.There were 35 samples, 22 trifuse and 13 quadfuse.This investigation will cover 6 of the quadfuse sets.Upon initial visual examination, the sets confirmed the report of component damage, with the male luer spin collar being cracked.In some cases, the collar was completely broken off the set.The samples were sent for further investigation to the supplier of the component.Device / batch history records (dhr/bhr) for batch 25039189 were reviewed to determine if there was a potential manufacturing or material issue related to the reported complaint.Review of in-process and final inspection records confirmed that all required inspections were completed and met established acceptance criteria.The supplier of the component confirmed the failure, but was unable to define the root cause or trace it to their process.Due to the ongoing issue with the mz9283 quadfuse and mz9281 trifuse sets, the investigation has been escalated to a cross-functional team, and a funded project has been opened.The project will further investigate the issue.

• Brand Name: BD MAXZERO MINIBORE QUAD-FUSE 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: 24783532
• Report Number: 9616066-2026-00883
• Device Sequence Number: 13243224
• Product Code: FPA
• UDI-Device Identifier: 10885403230660
• UDI-Public: (01)10885403230660
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: MZ9283
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown