MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. Unspecified BD Infusion Set; Intravascular administration set

Catalog Number	Unknown
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
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
It was reported that unspecified bd infusion set was damaged.The following information was received by the initial reporter with the following verbatim.It was reported by customer that the roller clamp on the iv administration set is difficult to adjust drip rate, and it is leaving marks on the iv tubing itself.
Event or Problem Description
It was reported that unspecified bd infusion set had clamp damaged.
Additional Manufacturer Narrative
Mdr was submitted for clamp damaged and supplemental was filed for correction after further evaluation the original mdr was correct but it was for unspecified bd infusion set.

• Brand Name: Unspecified BD Infusion 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 22244
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25326816
• Report Number: 9616066-2026-01410
• Device Sequence Number: 15929659
• Product Code: FPA
• UDI-Device Identifier: 00382903819232
• UDI-Public: (01)00382903819232
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K251654
• 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,Followup,Followup
• Report Date (Section B): 09/22/2026

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: Unknown
• Device Lot Number: unknown
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/21/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Supplement Date Received by Manufacturer: 06/08/2026; 09/17/2026; 09/22/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/08/2026; 09/17/2026; 09/22/2026
• 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