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

Model Number	20128E
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 bd alaris smartsite extension set experienced occlusion.The following information was provided by the initial reporter: i have two sets of the smartsite extension set filter tubing with ref #(b)(4) that would not prime for staff.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 19oct20223 investigation summary: 2 samples were returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The sets were attached to a bd primary set primed with 85% glycerin / 15% water solution and allowed to prime using gravity.The sets were unable to be primed using gravity.A quality notification was sent to the supplier.During the supplier investigation excess solvent was observed.A quality notification was sent to the manufacturer.The manufacturer investigation found the main root cause to be attributed to double gumming (repeat the solvent application twice).As a preventative action a quality notification was created for this defect.A device history record review for model 20128e lot number 21129190 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2021.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
It was reported that 2 bd alaris smartsite extension set experienced occlusion.The following information was provided by the initial reporter: i have two sets of the smartsite extension set filter tubing with ref #(b)(4) that would not prime for staff.

• 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 ; 8015296192
• MDR Report Key: 14477863
• Report Number: 9616066-2022-00659
• Device Sequence Number: 5176859
• Product Code: FPA
• UDI-Device Identifier: 37613203011847
• UDI-Public: 37613203011847
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: Other
• Device Model Number: 20128E
• Device Catalogue Number: 20128E
• 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: 05/11/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 11/08/2022
• 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