MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD SPECIALTY LOW-PRESSURE EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX5302
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd specialty low-pressure extension set was damaged.The following information was provided by the initial reporter: the male luer on the bd alaris pump infusion set (ref.(b)(4)) broke off in female y-sites on the bd maxguard pressure rated extension set (minibore) with needless y-site (ref (b)(4)).Additional information received from the customer: describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.There were no reports of pt harm or injury.The staff involved in the care of the pt had to replace the iv tubing with new supplies.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
One sample of material number mx5302 was received for quality evaluation.The sample submitted has the tip of a male luer lodged into the inlet port of the y-site connector.The issue presented by the sample submitted is not with the reported set of mx5302.The sample of mx5302 has a male luer connector stuck in the y-site smartsite, however, mx5302 is not damaged.The tip of the male luer connector cannot be removed from the sample because the dried blood has now solidified the luer tip to the port.The customer complaint of component damage - leak could not be verified.A root cause analysis was not conducted because the failure was not with product mx5302.The broken luer was from the primary infusion set (2420-0007).The primary infusion set failure was investigated under bd complaint number pr 12555706.

• Brand Name: BD SPECIALTY LOW-PRESSURE EXTENSION SET
• 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: 22822486
• Report Number: 9616066-2025-02430
• Device Sequence Number: 15898621
• Product Code: FPA
• UDI-Device Identifier: 10885403237560
• UDI-Public: (01)10885403237560(17)271129(10)24119374
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 10/24/2025

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: MX5302
• Device Lot Number: 24119374
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown