MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE SECONDARY SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 10013364

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 09/01/2021

Event Type  malfunction  

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 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
• 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
• MDR Report Key: 12745684
• MDR Text Key: 279892450
• Report Number: 9616066-2021-52359
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403221927
• UDI-Public: 10885403221927
• Combination Product (y/n): N
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10013364
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 65 YR
• Patient Weight: 69