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

Catalog Number	10015012
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
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 the bd alaris smartsite infusion set had a kink / bend.The following information was provided by the initial reporter: hanging new tpn line and kink noted in the tpn line pass the buretrol and drip chamber.Concerned that tubing would leak from this kinked area (not connected to the patient).A few staff have informed that they have noted the tpn tubing being packaged differently.
Additional Manufacturer Narrative
One sample model 10015012 was returned for investigation.The set was examined for defects and abnormalities.The tubing was kinked right below the drip chamber.No other defects or abnormalities were observed.While manipulating the kink the tubing ripped and is now leaking from the kink.The customer complaint was verified and a quality notification was sent to the manufacturer.The most potential root cause that generates the kink in the tubing sleeve/drip chamber is an combination of an excess of solvent applied to the engagement and an improper handling of the tubing during the assembly process and coiling of the set due since production personnel did not follow correctly the assembly procedures.Quality alert was displayed on dec 04th, 2025, to communicate to the personnel involved in the assembly process of model 2420-0007 regarding the condition reported in the complaint by the customer, the importance of following assembly instructions stated in the standard work instruction.A device history record review 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 INFUSION 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: 23624960
• Report Number: 9616066-2025-03557
• Device Sequence Number: 13024413
• Product Code: FPA
• UDI-Device Identifier: 10885403233951
• UDI-Public: (01)10885403233951(10)25085214
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2026

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: 10015012
• Device Lot Number: 25085214
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown