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

Catalog Number	2477-0007
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.A 2477-0007 product was not available for investigation of pr 14925632; the lot number was not available.The feedback provided by the customer states that, "it was observed that one of the dual side clamps was not fully secured even though clamp has applied." no further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.The lot number was unavailable and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.In this instance, without the complaint sample to examine it has not been possible to conclusively link this feedback to a specific failure mode; however, a review of the customer feedback database indicates that this is a rare occurrence with this customer being the only customer to provide this type of feedback against the 2477-0007 set in the past 12 months.
Event or Problem Description
The following information was provided by the initial reporter: it was reported that : i am writing to bring to your attention three separate incidents recently identified by my team involving the following product: infusion set ¿ alaris primary, dual spike blood, 180 micron filter, with 1 smartsite needle-free port.It was observed that one of the dual side clamps was not fully secured even though clamp has applied.This resulted in the fluid bag emptying prematurely at the end of the transfusion.We are currently in the process of identifying the specific lot/batch involved.In the meantime, i would like to ask whether your team is aware of any similar incidents or reports from other sites that may be related.Please let me know if you require any further details from our end.

• Brand Name: BD ALARIS SMARTSITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 25232469
• Report Number: 9616066-2026-01333
• Device Sequence Number: 10238495
• Product Code: FPA
• UDI-Device Identifier: 07613203019460
• UDI-Public: (01)07613203019460
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2026

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: Health Professional
• Device Catalogue Number: 2477-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown