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

Model Number	20028E
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device lot #: h37020028e19 was reported, however, this is not a lot # manufactured for the reported catalog #.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd alaris smartsite extension set the tubing was damaged.This occurred twice.This is report 1 of 2.There was no report of patient impact.The following information was provided by the initial reporter: incident date:(b)(6) 2023.¿this filter had 2 twisted and kinked areas in the tubing.This caused an occlusion alarm on the alaris pump and nurse changed the tubing.Ns was flowing through the tubing at the time.¿.Product: mfr 20028e, available for return.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 06-jul-2023.H.6.Investigation summary: a complaint of the set being kinked causing occlusion, was received from the customer.A photo of the packaging was received from the customer.A sample was received for investigation.Through visual inspection, the complaint of tubing kinked was confirmed.Kinks were seen above the filter and above the y-site.The kinked tubing was also opaquer with white colored bubbles in the tubing.A device history record review for model 20028e lot number 23029348 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 28feb2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing site was notified of this defect.After investigation, the potential root cause of kinked tubing could be related to an incorrect coiling of product by the assembler in combination with an excess of solvent between components due to opportunities with the solvent dispenser.This failure mode was addressed by improving the consistency of the solvent application between components, and the bushing of the solvent dispenser will be changed.Additionally, a quality alert was generated to communicate and reinforce the correct coiling of the product and solvent application between components.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
It was reported while using bd alaris smartsite extension set the tubing was damaged.This occurred twice.This is report 1 of 2.There was no report of patient impact.The following information was provided by the initial reporter: incident date:5/23/2023 ¿this filter had 2 twisted and kinked areas in the tubing.This caused an occlusion alarm on the alaris pump and nurse changed the tubing.Ns was flowing through the tubing at the time.¿ product: mfr 20028e, available for return.

• Brand Name: BD ALARIS SMARTSITE EXTENSION 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17159524
• Report Number: 9616066-2023-01212
• Device Sequence Number: 17942345
• Product Code: FPA
• UDI-Device Identifier: 07613203012393
• UDI-Public: (01)07613203012393
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2023

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 Model Number: 20028E
• Device Catalogue Number: 20028E
• Device Lot Number: UNKNOWN
• 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: 05/25/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 06/19/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown