MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A DE C.V. BD MAXGUARD EXTENSION SET W/ NEEDLELESS Y-SITE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX9182
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date of event is unknown; bd awareness date used.Device evaluation: two sets were returned for investigation.The failure was unable to be replicated despite applying back pressure.The root cause could not be determined because the issue could not be replicated.A device history record review was performed.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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
It was reported that the bd maxguard extension set w/ needleless y-site had flow issues.The following information was provided by the initial reporter: customer has reported issues of the backcheck valve on the mx9182 not working correctly.He has saved the sample and has the lot # information as well.Additional information received from the customer: could you please provide a detailed description of the issue you encountered with backcheck valve on the mx9182? we identified an issue with the backcheck valve¿s intended one way valve.When slight positive pressure is applied on the backcheck side of the valve such as during medication infusion, flushing, or manual injection through a luer-lock access port the valve does not consistently prevent retrograde flow.Under these conditions, the applied pressure appears to bypass the valve diaphragm, allowing fluid to travel backward into the upstream line.This occurs with minimal force, consistent with normal flushing or medication administration, and does not require excessive pressure.As a result, the valve fails to reliably maintain directional flow as designed.This behavior creates the potential for unintended backflow into the iv line, which may impact medication delivery accuracy and poses a clinical safety concern.Can you please provide an exact date of event in this format mm-dd-yyyy? 06/01/26 ¿ 06/05/26 please share the lot number associated with reported issue.Mx9182 describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Good catch no harm.

• Brand Name: BD MAXGUARD EXTENSION SET W/ NEEDLELESS Y-SITE
• 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: 25667849
• Report Number: 9616066-2026-01661
• Device Sequence Number: 5596838
• Product Code: FPA
• UDI-Device Identifier: 10885403424304
• UDI-Public: (01)10885403424304
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2026

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: MX9182
• Device Lot Number: 25095736
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown