MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE EXTENSION SET; 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	10/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd alaris smartsite extension set the tubing would not prime properly three times.There was no report of patient impact.The following information was provided by the initial reporter: today, we had three more instances where the tubing would not prime.
Additional Manufacturer Narrative
Investigation summary: three samples (model #20159e) were returned by the customer.It was reported by the customer that they had three more instances where tubing would not prime.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.Each returned sample has two smartsite ports.Each smartsite port of each sample was connected to a cut off syringe tip to check that the fluid path is in an activated position/open when connected to a syringe.Each port was then attempted to be flushed with water using a 10ml bd syringe to confirm an open fluid path.Each returned sample had one smartsite port that was open and able to be flushed, and one smartsite port that was not open and was unable to be flushed.The customer complaint can be verified.A root cause was unable to be determined.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.

• 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: 15995043
• Report Number: 9616066-2022-01973
• Device Sequence Number: 5961528
• Product Code: FPA
• UDI-Device Identifier: 37613203012288
• UDI-Public: (01)37613203012288
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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
• Report Date (Section B): 11/30/2022

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 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: 10/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2022
• Initial Report FDA Received Date: 12/16/2022
• 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