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

Catalog Number	20019E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2024
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 bd alaris smartsite extension set was damaged the following information was received by the initial reporter with the following verbatim verbatim: trifuse was broken from the connector side and blood backed up into the umbilical line, that was when the nurse noticed the breakage.
Event or Problem Description
Material#: 20019e.Batch#: 22125358.It was reported by the customer that trifuse was broken from the connector side and blood backed up into the umbilical line, that was when the nurse noticed the breakage.Verbatim: trifuse was broken from the connector side and blood backed up into the umbilical line, that was when the nurse noticed the breakage.Additional info: 1.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.Trifuse was connected to the patient and the blood was backing up into the line.This event also resulted in an open system increasing the potential for line infection.2.Can you please provide the lot number associated with reported issue? i do not have the lot # for the trifuse.The lot number for the smartsite extension that was malfunctioning today is (10) 22125358 ref: 20019e.3.Total number of occurrences? trifuse- 1, smartsite extension- 2.4.Sample available is mentioned as yes, are you able to provide the address of the facility for us to ship the return label? xxxxx.Additional info: 1.Any adverse event or serious injury reported to a patient or healthcare professional? if yes, please provide the details.No adverse event or injury, malfunction was found during preparation and the patient was not connected to the device.2.Is there any available for investigation from material# 20019e? yes, i will be sending it ).
Additional Manufacturer Narrative
It was reported by the customer that trifuse was broken from the connector side and blood backed up into the umbilical line, that was when the nurse noticed the breakage.Two samples were received for quality evaluation.Visual examination was conducted and there were no abnormalities or damages identified.The trifuse sets were then tested to see if they allowed for flow through each of the extension set lines.A needless syringe was attached to each of the smartsites of the trifuse lines to see if they allowed flow through the line.There were no leakages, air-in-line or occlusion issues identified when testing the two trifuse sets.The customer complaint of component damage - leak could not be confirmed.A root cause was not determined because the reported failure was not replicated.A device history record review 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: 20758447
• Report Number: 9616066-2024-01717
• Device Sequence Number: 9302615
• Product Code: FPA
• UDI-Device Identifier: 07613203012010
• UDI-Public: (01)07613203012010
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061285
• 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): 01/13/2025

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 Expiration Date: 12/13/2025
• Device Catalogue Number: 20019E
• Device Lot Number: 22125358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 01/13/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown