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	Break (1069)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	02/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite extension set was damaged the following information was received by the initial reporter with the following.One of my staff nurses was utilizing the bd smartsite 3 needle free valve extension set (ref20038e).Once she primed her fluids through the extension set and tried to connect the extension set to her central line, the product snapped right at the connector.This broke sterility and required the rn to re-prime all of her iv fluids under sterile conditions.The patient did not respond well to being off iv pressors for blood pressure due to this delay.
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
The customer reported the product snapped, and returned a photo of the affected ext set, the photo only investigation verified the complaint of component damage, from the missing male luer collar.Due to the photo-only investigation the manufacturing plant was unable to find the root cause for the missing male luer.A device history record review could not be performed because the lot number is unknown.

• 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: 21617512
• Report Number: 9616066-2025-00537
• Device Sequence Number: 12434143
• Product Code: FPA
• UDI-Device Identifier: 07613203011976
• UDI-Public: (01)07613203011976
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 04/09/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/10/2025
• 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