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	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 6 of the bd alaris¿ smartsite¿ extension set clogged.The following information was provided by the initial reporter: we have been experiencing some issues with our.2 micron filter not priming.The rn will attempt to prime the medication, but it will stop when it gets to the filter.The rn will then hook up a 10ml normal saline syringe and try to prime but is met with resistance.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4 device expiration date: unknown.H.4.Device manufacture date: unknown.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: device available for eval?: yes.Returned to manufacturer on: 16-may-2023.Investigation summary: one sample (model #20028e, lot #22049384) was returned by the customer.It was reported by the customer that they are experiencing some issues with our.2-micron filter not priming.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The sample was connected to a 10ml bd syringe, and attempted to be flushed with water.The sample was unable to be flushed.The sample appeared to be occluded at the outlet of the filter.The sample was further examined under magnification where an occlusion can be observed.The customer complaint can be verified in this sample.A quality notification was sent to the manufacturer.The manufacturer was able to confirm the failure.After investigation, the potential root cause of occlusion between the tubing (pn 605518-000) and filter (pn 10012217) was related to excess solvent by failure of the solvent dispenser.An opportunity was detected in the bushing selection to decrease the amount of solvent.Corrective and preventive actions: the failure mode was addressed and as part of the actions taken, the use of a grooved bushing will be evaluated to reduce the amount of solvent.Additionally, a quality alert was generated on (b)(6) 2023 to reinforce the escalation of failure in solvent dispenser.We will continue to monitor related complaints to take the necessary actions to address this failure mode.A device history record review for model 20028e lot number 22049384 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 29apr2022.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
It was reported that 6 of the bd alaris¿ smartsite¿ extension set clogged.The following information was provided by the initial reporter: we have been experiencing some issues with our.2 micron filter not priming.The rn will attempt to prime the medication, but it will stop when it gets to the filter.The rn will then hook up a 10ml normal saline syringe and try to prime but is met with resistance.

• 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: 16849321
• Report Number: 9616066-2023-00797
• Device Sequence Number: 6865541
• Product Code: FPA
• UDI-Device Identifier: 07613203012393
• UDI-Public: (01)07613203012393
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 10/16/2023

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: 04/10/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 10/19/2023
• 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