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

Catalog Number	20039E
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
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 the bd alaris smartsite extension set had connection issues.The following information was provided by the initial reporter: the infusion sets (straight type) in this batch cannot be tightened.Additional information received from the customer: please return the affected product(s) and any connecting products (with its original packaging if possible) for investigation? no please confirm the lot number(s) affected; is it both 25095555 and 25095556? yes please confirm how the fault was identified? customer notification.Please confirm if the fault was identified during priming or during infusion? if during infusion, how long into the infusion? during infusion; time unknown.Please confirm the make and model of the connecting product(s)? unknown.Please confirm if there is any visible damage on the set, such as cracks, flashes or deformation of the piston? unknown.Please confirm the exact location of the reported fault within the set? unknown.Was there any patient harm? no.Was there an under infusion? unknown.Could you please provide the number of quantities affected? if applicable.Unknown.
Additional Manufacturer Narrative
Investigation result: no 20039e sample was available for investigation.The customer reported that the affected samples are from 25095555 and 25095556 and that "the infusion sets (straight type) in this batch cannot be tightened." as part of the investigation, the customer only provided a photograph of the packaging of the sample.No further information or photographs of the affected product were available to assist the investigation.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot: 25095555 and 25095556 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.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.
Event or Problem Description
No additional information.

• Brand Name: BD ALARIS SMARTSITE EXTENSION SET
• 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: 24492697
• Report Number: 9616066-2026-00557
• Device Sequence Number: 20106725
• Product Code: FPA
• UDI-Device Identifier: 07613203011952
• UDI-Public: (01)07613203011952(17)280916(10)25095556
• 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
• Report Date (Section B): 03/25/2026

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: 25095556
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown