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

Catalog Number	20039E
Medical Device Problem Codes	Complete Blockage (1094); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite extension set was occluded.The following information was provided by the initial reporter: the blue semi-transparent connector portion of the 20039e pinless connector has completely.
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
No additional information.
Additional Manufacturer Narrative
Investigation result: no 20039e sample was available for investigation.The customer reported that the affected sample was from lot 25055366 and that "the blue semi-transparent connector portion of the 20039e pinless connector has completely".As part of the investigation, the customer also provided a photograph of the affected sample; analysis of the photograph confirmed that the reported failure mode was a misassembled set with another male luer assembled instead of a smartsite.The details of this feedback were forwarded to the manufacturing site for investigation.Their analysis confirmed that the misassembly is most likely to have been caused by human error during the manual assembly process, whereby the operator inadvertently assembled a male luer instead of the smartsite.A review of the production records for lot 25055366 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In order to reduce the likelihood of operator error, the production personnel have been informed of this feedback to ensure that they are following the correct assembly process.A review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the 20039e product over the past 12 months.
Additional Manufacturer Narrative
Following the submission of the initial mdr, post investigation results reveal that the reported failure of occlusion was actually misassembly.This is not a reportable device malfunction.This mdr report #9616066-2025-03725 will be voided.
Event or Problem Description
Post investigation results reveal that the reported failure of occlusion was actually misassembly.This is not a reportable device malfunction.

• Brand Name: ALARIS SMARTSITE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• 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: 23758131
• Report Number: 9616066-2025-03725
• Device Sequence Number: 10105718
• Product Code: FPA
• UDI-Device Identifier: 07613203011952
• UDI-Public: (01)07613203011952(17)280515(10)25055366
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K061285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2026

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: 20039E
• Device Lot Number: 25055366
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 02/12/2026; Not provided
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 03/02/2026; 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown