MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. MICROBORE EXTENSION SET, IV CONNECTOR.; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	MZ9267
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.E1.Address information was not provided; therefore, (b)(6) was used as the state.No product or photo was returned by the customer.The customer complaint of component damage - no leak could not be verified due to the product not being returned for failure investigation.A device history record review for material# mz9267 and lot# 25039145 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07 mar 2025.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
Hospital has been using mz9267 and the spin luer lock has cracked.Lot # 25039145.No patient harm.
Additional Manufacturer Narrative
It was reported by the customer that the spin luer lock has cracked.One sample was received for quality evaluation.Visual inspection of the sample shows that the male luer connector spin collar was cracked.The customer complaint of component damage was confirmed.Based on the damage seen on the sample submitted and information provided by the customer regarding the cleaning of the luer connector using chlorhexidine, the root cause of the issue is most likely due to applying an antiseptic or alcohol on the connector, and not allowing it to dry before making the connection.Not allowing the antiseptic to dry before making the connection can make the luers brittle, making the luer components easy to crack.A device history record review for material# mz9267 and lot# 25039145 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07mar2025.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR.
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24192753
• Report Number: 9616066-2026-00134
• Device Sequence Number: 21294706
• Product Code: FPA
• UDI-Device Identifier: 10885403240720
• UDI-Public: (01)10885403240720(17)280306(10)25039145
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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: Health Professional
• Device Catalogue Number: MZ9267
• Device Lot Number: 25039145
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown