MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE¿ EXTENSION SET, BIFUSE 2 SMARTSITE¿ NEEDLE-FREE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number	20159E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.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, bifuse 2 smartsite¿ needle-free connector the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that there are issues flushing meds through the extension sets.They have issues flushing meds through them.
Additional Manufacturer Narrative
H6: investigation summary: two samples were returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was attached to a cut off bd syringe to see if a fluid path can be observed while the piston is in the activated position.A fluid path was observed while the piston was in the activated position.The smartsite was then connected to a 10 ml bd syringe filled with blue dye water and the set was attempted to be flushed.The set was successfully flushed.The customer complaint that there are issues flushing meds through the extension sets could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 20159e lot number 22029775 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 22feb2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A trend for this occlusion issue has been identified for this product line.A capa (corrective action preventative action) 1998036 has been initiated, and a team has been assembled in order to investigate the issue.
Event or Problem Description
It was reported while using bd alaris smartsite¿ extension set, bifuse 2 smartsite¿ needle-free connector the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that there are issues flushing meds through the extension sets.They have issues flushing meds through them.

• Brand Name: BD ALARIS SMARTSITE¿ EXTENSION SET, BIFUSE 2 SMARTSITE¿ NEEDLE-FREE CONNECTOR
• 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: 14349170
• Report Number: 9616066-2022-00569
• Device Sequence Number: 20063974
• Product Code: FPA
• UDI-Device Identifier: 37613203012288
• UDI-Public: 37613203012288
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 05/16/2022

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 Expiration Date: 02/17/2025
• Device Model Number: 20159E
• Device Catalogue Number: 20159E
• Device Lot Number: 22029775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Supplement Date Received by Manufacturer: 05/16/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2022
• 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