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

Catalog Number	10012866
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One sample was returned for investigation.The set was examined for defects and abnormalities.The vents appeared to be wetted out.No other defects or abnormalities were observed.The set was flushed with water and leak was seen coming from both vents.Additional air under water test was performed.The set was pressurized with about 10psi and the vent was submerged under water.There was a steady stream of air bubbles coming from the filter vent.This would indicate that there is no issue with damage/ holes in the membrane.The reason for the membrane leaking is that the hydrophobicity of the membrane must have been compromised during use and not during the manufacturing process.A device history record review could not be performed because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.
Event or Problem Description
It was reported that bd alaris extension set was leaking.The following information was received by the initial reporter with the following verbatim: it was reported by the customer that tpn filter was found leaking by a bedside nurse.

• Brand Name: BD ALARIS 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: 24204409
• Report Number: 9616066-2026-00161
• Device Sequence Number: 9635565
• Product Code: FPA
• UDI-Device Identifier: 10885403233777
• UDI-Public: (01)10885403233777
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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
• Report Date (Section B): 01/13/2026

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: 10012866
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 01/28/2026
• 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