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	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite extension set is difficult to disconnect.The following information was provided by the initial reporter: unhooking iv tubing from j loop on a peripheral iv.The tubing unscrewed but would not come out of the j loop hub.I pulled harder on the connection part and the plastic tip that goes into the hub broke off and then the iv started to backflow since there was an open spot in the hub.
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
It was reported by customer that the tubing unscrewed but would not come out of the j loop hub.One sample of product 20039e was submitted for quality evaluation.The sample submitted had piece of a male luer connector in the y-site connector port broken off inside the port.The piece of male luer was pulled out of the smartsite port using a pair of plyers to see if the male luer piece is stuck or bonded to the y-site port.The small piece of male luer was easily removed without any excess force.The extension set was then primed to see if there were any leaks or if there was any issues with flow or air-in-line.There were no issues identified with the extension set.Although a piece of a male luer adapter was found broken off inside the y-site smartsite of the assembly, the customer complaint of connection issues - unable to disconnect could not be verified.A root cause analysis was not conducted due to the failure not being verified.A device history record review for model 20039e lot number 25035282 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• 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: 22568698
• Report Number: 9616066-2025-02094
• Device Sequence Number: 15764858
• Product Code: FPA
• UDI-Device Identifier: 07613203011952
• UDI-Public: (01)07613203011952(10)25035282
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K061285
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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: 20039E
• Device Lot Number: 25035282
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 09/24/2025
• 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