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

Catalog Number	10014881
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2025
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 smartsite secondary set was leaking.The following information was received by the initial reporter with the following verbatim.It was reported by customer that breakage/leakage.
Additional Manufacturer Narrative
Three samples model 10014881 were unopened, two were open/used and deconned and 104 were out of the package but not used.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were primed with water and the two opened/used samples leaked at the junction between the male luer and tubing.No issues found with the unopened samples.Leakage between tubing-sleeve and male luer could be related to an incorrect tubing expansion in combination with an incorrect solvent application between components (excess) with by the assembler.Reported lot was manufactured on july 30th, 2025, before actions state implemented where the standard work instruction was updated to include the use of a new fixture to carry out correctly the expansion of sleeve and tubing solvent application and to assure the correct assembly between the tubing-sleeve/male luer.Additionally, a quality alert was created and communicated.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 SMARTSITE SECONDARY SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 23333681
• Report Number: 9616066-2025-03158
• Device Sequence Number: 18187359
• Product Code: FPA
• UDI-Device Identifier: 10885403221934
• UDI-Public: (01)10885403221934(17)280729(10)25075707
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2025

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: 10014881
• Device Lot Number: 25075707
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 12/15/2025
• Initial Report FDA Received Date: 10/19/2025
• Supplement Report FDA Received Date: 12/15/2025
• 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