MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. De C.V. BD Alaris Extension Set; Intravascular administration set

Catalog Number	ME2020
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris extension set had foreign matter the following information was received by the initial reporter with the following verbatim it was reported by customer that the black speck present within the tubing line.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• Brand Name: BD Alaris 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 22244
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. De C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50876666
• Report Number: 9616066-2026-02420
• Device Sequence Number: 21498147
• Product Code: FPA
• UDI-Device Identifier: 10885403236259
• UDI-Public: (01)10885403236259
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 25115866
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown