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

Catalog Number	10013364
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Medical device expiration date: unknown.Fda notified?: the initial reporter also notified the fda via medwatch #(b)(4).Device manufacture date: unknown.Investigation summary: a complaint of tubing falling apart causing leakage during infusion was received from the customer.A photo was provided for investigation.In the photo, the drip chamber is seen separated from the rest of the set.The customer complaint was confirmed.A device history record review could not be performed on the provided model number because a lot number was not provided by the customer.Due to a physical sample not being received, a full investigation could not be performed, and a root cause could not be 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 bd alaris smartsite secondary set was damaged, causing leakage.The following information was provided by the initial reporter: "when the nurse arrived at the bedside, another nurse, who had gone to assist the patient prior to the first nurse's arrival, was found to be holding oxaliplatin bag that had been severed from the tubing.".

• Brand Name: BD ALARIS SMARTSITE SECONDARY SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12745684
• Report Number: 9616066-2021-52359
• Device Sequence Number: 11882322
• Product Code: FPA
• UDI-Device Identifier: 10885403221927
• UDI-Public: 10885403221927
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2021

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: Health Professional
• Device Catalogue Number: 10013364
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 65 YR
• Patient Weight: 69