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

Catalog Number	2300E-0500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris smartsite bag access device was broken the following information was received by the initial reporter with the following verbatim the smartsite connector is breaking off of the bag spike.The customer has retained affected samples, also has a picture.They have 12 cases of product with the same lot# that need to be returned and replaced.
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
It was reported that the smartsites were creaking from the spike.500 unused samples were returned for investigation.He sets were examined for defects and abnormalities.No defects or abnormalities were observed.Excess force was applied to the samples samples were able to be snapped at the spike.A quality notification was sent to the manufacturer.From the manufacturer's investigation, after investigation, and by reviewing the process, it was not possible to determine the root cause due to not being able to replicate the failure reported during the different scenarios created or confirm which was the factor or combination of factors that generate the condition reported, however, process improvements were taken.As an improvement process, preventive maintenance a new fixture will be implemented by updating the spike press procedure approved on (b)(6) 2024, to specify that preventive maintenance is required for this fixture to ensure that the equipment is in optimal conditions for use.Current control measures are adequate to control the risk.We will continue to track and trend and if any negative trend is observed, proper actions will be deemed necessary.A device history record review for model 2300e-0500 lot number 24015265 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 20jan2024.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
No additional info.

• Brand Name: BD ALARIS SMARTSITE 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: 19072864
• Report Number: 9616066-2024-00549
• Device Sequence Number: 4682759
• Product Code: FPA
• UDI-Device Identifier: 10885403235023
• UDI-Public: (01)10885403235023
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/12/2024

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 Catalogue Number: 2300E-0500
• Device Lot Number: 24015265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 08/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown