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	Nonstandard Device (1420); Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
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 verbatim.It was reported by customer that item is unable to be flushed of medication.
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
Samples.
Additional Manufacturer Narrative
27 unused me2020 microbore extension sets were received and tested by our quality team with the customer's complaint of occlusion/ fluid blockage.All 27 sets were visually inspected then primed and infused with saline solution and no issues were observed.The sets received were functional and performed as intended.The customer's complaint could not be verified and the root cause remains unknown without the affected device for investigation.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.
Event or Problem Description
Unused samples.
Additional Manufacturer Narrative
Investigation summary: 27 unused me2020 microbore extension sets were received and tested by our quality team with the customer's complaint of occlusion/ fluid blockage.All 27 sets were visually inspected then primed and infused with saline solution and no issues were observed.The sets received were functional and performed as intended.The customer's complaint could not be verified and the root cause remains unknown without the affected device for investigation.The production history was analyzed and there were no issues found during quality inspections that would lead to this issue.

• 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: 23528794
• Report Number: 9616066-2025-03439
• Device Sequence Number: 16003089
• Product Code: FPA
• UDI-Device Identifier: 10885403236259
• UDI-Public: (01)10885403236259(17)300716(10)25075471
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 01/28/2026

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: 25075471
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 01/22/2026; 01/22/2026
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 01/27/2026; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown