MAUDE Adverse Event Report: BD ALARIS¿ SMARTSITE¿ SECONDARY SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	10013364
Medical Device Problem Codes	Leak/Splash (1354); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: a complaint of several sets being broken and kinked was received from the customer.A photo was provided for investigation of this defect.No kinks in the tubing was seen however, it was observed that the drip chamber was separated from the rest of the set.The customer complaint of tubing kinked could not be confirmed.Separation was confirmed as a defect.A device history record review for model 10013364 lot number 20077256 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25jul2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.As a physical sample was not received, a full investigation could not be completed, and a root cause was not determined.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 3 bd alaris¿ smartsite¿ secondary sets' tubing separated and leaked chemo during use, and 3 sets had kinked tubing issues.The following information was provided by the initial reporter: "we have at least 3 documented of the tubing snapping off and leading to significant spills of chemo.Noticing kinks in the tubing at the chamber site and have been manually untwisting them.".

• Brand Name: BD ALARIS¿ SMARTSITE¿ SECONDARY SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12637941
• Report Number: 9616066-2021-52240
• Device Sequence Number: 11848304
• Product Code: FPA
• UDI-Device Identifier: 50885403221925
• UDI-Public: 50885403221925
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• 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): 09/20/2021

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: 07/25/2023
• Device Model Number: 10013364
• Device Catalogue Number: 10013364
• Device Lot Number: 20077256
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2020
• 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