MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ EXTENSION SET, PRESSURE RATED SMARTSITE¿ T-CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20041E
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 smartsite¿ extension set, pressure rated smartsite¿ t-connector the tubing connection was loose and leaked.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that it "leaks and will not attach all the way to the iv tubing".Verbatim: leaks and will not attach all the way to the iv tubing.
Additional Manufacturer Narrative
Investigation summary: a sample was received and tested by our quality team.The connection issue was immediately noticed when the set leaked during infusion testing with saline and connected to another device.The female luer was visually analyzed under microscope and a small crack down the side was realized.The luer showed no signs of manufacturer error.The root cause of this failure is unknown.There is a possibility that the luer cracked from being over tightened as seen in the past before.A device history record review for model: 20041e, lot number: 22055021 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 06may2022.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.
Event or Problem Description
It was reported while using bd smartsite¿ extension set, pressure rated smartsite¿ t-connector the tubing connection was loose and leaked.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer that it "leaks and will not attach all the way to the iv tubing".Leaks and will not attach all the way to the iv tubing.

• Brand Name: BD SMARTSITE¿ EXTENSION SET, PRESSURE RATED SMARTSITE¿ T-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: 15317335
• Report Number: 9616066-2022-01242
• Device Sequence Number: 5888700
• Product Code: FPA
• UDI-Device Identifier: 07613203011914
• UDI-Public: 07613203011914
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/11/2022

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: 05/06/2025
• Device Catalogue Number: 20041E
• Device Lot Number: 22055021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2022
• 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