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

Catalog Number	20038E
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite extension set was cracked.The following information was provided by the initial reporter: the connector used in the nicu and ccu for iv tubing bd smart site extension set, lot # (10) 24066937 cracked while in use on the infant.Additional information received from the customer: what was the impact to the patient? no.Did the reported issue result in any leaks? yes.What was the medication/fluid in use at the time of the event? d10.Was this a chemotherapy drug? no.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Four photos were provided for quality evaluation.Examination of the photos show that the male luer connection collar has cracks on them.The customer complaint of component damage was confirmed.The root cause for the issue seen can not be fully determined, however, the probable root cause for the issue is that alcohol or and antiseptic was used on the surfaces of the male luer and the corresponding female luer, and not allowing it to dry fully before making the connection.If the alcohol or antiseptic is not allowed to full dry, the luer materials can become brittle and crack.The manufacturing and supplier groups have been made aware of the issue and will be monitoring future production for any emerging trends.A device history record review for model 20038e lot number 24066937 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: BD ALARIS SMARTSITE 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22811872
• Report Number: 9616066-2025-02413
• Device Sequence Number: 18056589
• Product Code: FPA
• UDI-Device Identifier: 07613203011976
• UDI-Public: (01)07613203011976(17)270625(10)24066937
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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
• Report Date (Section B): 10/24/2025

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: 20038E
• Device Lot Number: 24066937
• 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: 07/22/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown