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

Catalog Number	10802688
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite gravity set had kinked tubing.The following information was provided by the initial reporter: we¿re having an issue with item#10802688, iv gravity set with check valve.The tube is bent making iv fluid unable to pass through.All are from lot#(10)25019445 and lot#(10)24129019.
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
One photo was received for quality evaluation.Inspection of the photo indicates that the infusion set is packaged and there is a noticeable kink of the tubing at the bottom of the drip chamber.The customer complaint of kinked tubing was confirmed.Investigation was forwarded to manufacturing for root cause determination.After investigation, the potential root cause of kinked tubing between tubing and drip chamber could be related to issues with the solvent dispenser, incorrect solvent application, incorrect arraignment of the component inside the pouch or keep tube in fixture fx-2747 by the assembler.No corrective actions were implemented because the manufacturing location that produced this batch of product has been deactivated.The product will be produced at a new manufacturing facility.Additionally, the failure mode was addressed with a quality alert created to communicate the failure at the new production location to avoid the issue in future production.A device history record review for model 10802688 lot number 25019445 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 GRAVITY 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: 22680261
• Report Number: 9616066-2025-02192
• Device Sequence Number: 9447473
• Product Code: FPA
• UDI-Device Identifier: 10885403234439
• UDI-Public: (01)10885403234439(10)25019445
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• 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): 10/14/2025

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: 10802688
• Device Lot Number: 25019445
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 10/14/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/15/2025
• 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