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

Catalog Number	10011865
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
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 extension set was occluded the following information was received by the initial reporter with the following verbatim it was reported by customer that pt infusion pump beeping downstream occlusion, upon assessment noticed filter was the issue and clogged.
Additional Manufacturer Narrative
One sample model 10011865 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed with water and an infusion was performed.No occlusion was observed.The customer complaint was unable to be replicated.It is possible that the medication caused the blockage from the filter actively filtering out larger particulates.A device history record review could not be performed on material 10011865 because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• 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: 23950113
• Report Number: 9616066-2025-04061
• Device Sequence Number: 7875127
• Product Code: FPA
• UDI-Device Identifier: 10885403233647
• UDI-Public: (01)10885403233647
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 01/15/2026

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: 10011865
• Device Lot Number: UNKNOWN
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 01/02/2026
• Supplement Report FDA Received Date: 01/16/2026
• 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 Age: 17 YR
• Patient Sex: Female