MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD SMARTSITE¿ EXTENSION SET, 1 SMARTSITE¿ NEEDLE-FREE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20059E
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that during ct infustion with bd smartsite¿ extension set, 1 smartsite¿ needle-free connector the tubing was defective.This is the 2nd of 2 events.The following information was provided by the initial reporter: my clinicians had two of our j loops (smartsite¿ extension set) pop during a ct infusion.They used 3.5 pressure.They determined the iv catheter worked on hub, so that wasn't the issue.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: device available for eval?: yes.Returned to manufacturer on: 21-jul-2023.Investigation summary: one sample was received for quality investigation.The customer complaint of tubing defective was confirmed by investigation.Evaluation of the extension set submitted show that the tubing was burst just before the male luer adapter connection.A device history record review for model 20059e lot number 22099016 was performed.The search showed that a total of 17,603 units in 1 lot number was built on 01sep2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the failure could not be determined.The manufacturing location has been made aware of the failure and an investigation could not indicate an issue with the tubing that may have caused it to burst in the manner seen in the sample.The clinical team has been contacted with the customer regarding the issue, in order to determine if further training or guidance is needed for the proper use of the extension sets.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that during ct infusion with bd smartsite¿ extension set, 1 smartsite¿ needle-free connector the tubing was defective.This is the 2nd of 2 events.The following information was provided by the initial reporter: my clinicians had two of our j loops (smartsite¿ extension set) pop during a ct infusion.They used 3.5 pressure.They determined the iv catheter worked on hub, so that wasn't the issue.

• Brand Name: BD SMARTSITE¿ EXTENSION SET, 1 SMARTSITE¿ NEEDLE-FREE 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 ; 8448235433
• MDR Report Key: 17295236
• Report Number: 9616066-2023-01399
• Device Sequence Number: 3994705
• Product Code: FPA
• UDI-Device Identifier: 07613203012317
• UDI-Public: 07613203012317
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 10/20/2023

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: 09/01/2025
• Device Catalogue Number: 20059E
• Device Lot Number: 22099016
• 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: 06/20/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 07/10/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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