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	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 22029775.Medical device expiration date: 17-feb-2025.Device manufacture date: 17-feb-2022.Medical device lot #: 21119807.Medical device expiration date: 05-nov-2024.Device manufacture date: 05-nov2021.Medical device lot #: 22039080.Medical device expiration date: 04-mar-2025.Device manufacture date: 04-mar-2022.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that 5 bd alaris smartsite extension sets from lot 22039080, 1 set from lot 21119807, and 3 sets from lot 22029775 experienced flow issues.The following information was provided by the initial reporter: customer stated the device is not letting fluid flow properly.
Additional Manufacturer Narrative
H.6.Investigation summary: three samples (model #20159e), nine samples (model #20159e), and five samples (model #20159e) were returned by the customer.It was reported that the device is not letting fluid flow properly.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The samples were connected to a cut off syringe tip to check that the fluid path is in an activated position/open when connected to a syringe.The samples were then attempted to be flushed with water using a 10ml bd syringe to confirm an open fluid path.The fluid paths of two samples were open and those samples were able to be flushed.The failure was unable to be replicated in these samples.The fluid path of one sample was not open and was unable to be flushed.The customer complaint can be verified in this sample.A root cause was unable to be determined.Due to an increase in incidents of this failure mode, a trend for this occlusion issue has been identified for this product line, a capa (corrective action preventative action) has been initiated, and a team has been assembled in order to investigate the issue.A device history record review for model 20159e lot number 22039080 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07mar2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 20159e lot number 21119807 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 08nov2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that 5 bd alaris smartsite extension sets from lot 22039080, 1 set from lot 21119807, and 3 sets from lot 22029775 experienced flow issues.The following information was provided by the initial reporter: customer stated the device is not letting fluid flow properly.

• 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: 15108299
• Report Number: 9616066-2022-00958
• Device Sequence Number: 5255823
• Product Code: FPA
• UDI-Device Identifier: 37613203012288
• UDI-Public: 37613203012288
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 10/07/2022

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: 20159E
• Device Catalogue Number: 20159E
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 10/24/2022
• 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