MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD SMARTSITE ADD-ON BAG ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	10013365
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2023
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 add-on bag access device separated.The following information was received by the initial reporter with the verbatim: failure of ll smart site add- on bag access device.Multiple times a piece of it wiggled off very easily from the same lot #.Lack of adhesive or sealant to keep it all connected.
Additional Manufacturer Narrative
The customer reported the pieces wiggled off, and returned 4 used samples of material#: 10013365 and batch#: 22105622.The set was visually examined for defects and abnormalities.The issue of separation on the drip chamber and port was verified on 1 of the samples.The complaint of separation is verified, however no issues were observed with 3 of the 4 returned samples.The separated sample was examined under a microscope, and the insufficient solvent was found on the port.The manufacturing site found the root cause for the issue to be related to misalignment of press fixture and the solvent dispenser for the drip chamber.A quality notification was issued by the plant on 01feb2024 to align the assembly press and level the solvent dispenser.Device history record review for model 10013365 lot number 22105622 was performed.The search showed that a total of 18,003 units in 1 lot number was built on 24oct2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SMARTSITE ADD-ON BAG ACCESS DEVICE
• 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: 18476360
• Report Number: 9616066-2024-00012
• Device Sequence Number: 6895600
• Product Code: FPA
• UDI-Device Identifier: 27613203013912
• UDI-Public: (01)27613203013912
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K970485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2024

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 Expiration Date: 10/22/2025
• Device Catalogue Number: 10013365
• Device Lot Number: 22105622
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2023
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown