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

Model Number	30204E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd smartsite¿ extension sets, an additional open port was observed connected to the inflow and lacked the ability to close.The following information was provided by the initial reporter: "it was reported by the customer that the smartsite set had an extra open port on device.Verbatim: our ed found one of cardinal # al30204e smartsite¿ extension set, slide clamp(s), 1 smartsite¿ needle-free valve(s) 4" from spin male luer lock that had been made with an extra open port.It is directly connected to the inflow with nothing to close it off.Our ed director and charge nurse tested this and said it can be fatal since nothing stops air from entering the open port.".
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A complaint of a set having an extra y-site was received from the customer.A sample was returned for investigation.Through visual inspection, the customer complaint was confirmed.In place of the female luer, another y-site was assembled onto the set.The y-site was also missing the blue component inside the port.A device history record review for model 30204e, lot number 21059733 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 26may2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for this defect is an error in the assembly process during manufacturing.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SMARTSITE¿ EXTENSION SETS
• 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 ; 8015296192
• MDR Report Key: 13047657
• Report Number: 9616066-2021-52617
• Device Sequence Number: 5409496
• Product Code: FPA
• UDI-Device Identifier: 50885403235175
• UDI-Public: 50885403235175
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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: Health Professional
• Device Model Number: 30204E
• Device Catalogue Number: 30204E
• Device Lot Number: 21056733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 12/20/2021
• 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