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

Catalog Number	10014881
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2026
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 the bd alaris smartsite low sorbing secondary set was occluded.The following information was provided by the initial reporter: i am writing to report several incidents where the drug is now flowing through the bd smartsite low sorbing secondary set.Ref 10014881.The fluid will pass into the drip chamber but then is unable to go any further through the tubing.Additional information received from the customer: please can you confirm what medication was being administered? the issue occurred with both paclitaxel and docetaxel.Please can you confirm if the medication was stored in the refrigerator? if yes, was it allowed to reach room temperature before use? it was in the fridge but returned to room temperature before try to administer.Please can you confirm the make and model of the connecting products? equashield closed system spike was attached to bd smartsite low sorbing secondary set.Please can you confirm if there are any visible defects to the device i.E., cracks, flashes, kinks? there do not appear to be any visible defects.Please can you confirm if the connecting product has a luer slip or luer lock connection? luer.Please confirm whether the flow was completely or partially blocked? complete blocked please can you confirm the exact location of blockage? fluid cannot pass from the drip chamber into the tubing.

• Brand Name: BD ALARIS SMARTSITE LOW SORBING SECONDARY SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A DE C.V.; parque sur, el realito; blvd. 2000; tijuana 22250 ; MX 22250
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22250 ; MX 22250
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25263189
• Report Number: 9616066-2026-01368
• Device Sequence Number: 15749560
• Product Code: FPA
• UDI-Device Identifier: 10885403221934
• UDI-Public: (01)10885403221934(11)250730(17)280729(10)25075707
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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: 10014881
• Device Lot Number: 25075707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Supplement Date Received by Manufacturer: 07/07/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 07/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown