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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris smartsite gravity set had separated.The following information was provided by the initial reporter: the tubing has come out of the port sites rendering the iv tubing null and the tubing not continuous, sterile, nor closed.
Additional Manufacturer Narrative
E.1.Initial reporter addr 1: (b)(6).H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of separation other component - leak could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 10802688 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 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: 22330258
• Report Number: 9616066-2025-01712
• Device Sequence Number: 8429833
• Product Code: FPA
• UDI-Device Identifier: 10885403234439
• UDI-Public: (01)10885403234439
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown