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

Catalog Number	ME2020
Medical Device Problem Codes	Complete Blockage (1094); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxguard extension set was occluded.The following information was received by the initial reporter with the following: it was reported by customer that they have had multiple bd max guard microbore extension set ref me2020, lot: 25095198, that have not been patent.
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 model me2020, lot 25095198 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.Set was unable to be primed with water.Visual inspection under microscope showed signs of excess solvent near the male luer.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, it was possible to determine that the cause of the occlusion is excess of solvent trapped at bonded engagement building an occlusion fluid path.Occlusion in model me2020 is being addressed for the same model, failure mode where the next actions have been taken: - 100% inspection by flow test of the affected batch.- as a containment measure, 24 hours of rest were added to the standard work instruction additional, a quality alert was performed related to occlusion in model me2020, where the operators were notified about the complaint and, reinforced the importance of following the assembly instructions.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.

• Brand Name: BD MAXGUARD 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: 23824379
• Report Number: 9616066-2025-03805
• Device Sequence Number: 4993253
• Product Code: FPA
• UDI-Device Identifier: 10885403236259
• UDI-Public: (01)10885403236259(17)300903(10)25095198
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 02/03/2026

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: ME2020
• Device Lot Number: 25095198
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown