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

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2022

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 305366852
• Report Number: 9616066-2022-01242
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203011914
• UDI-Public: 07613203011914
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1