MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 40 INCH EXT W/2 VLV PORTS; INTRAVASCULAR ADMINISTRATION SET

Model Number 30263E

Device Problems Backflow (1064); Infusion or Flow Problem (2964)

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

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one sample was returned for investigation by the customer.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The sample was primed with saline.A bd secondary set was primed with blue dye and attached to the returned sample.Both sets were allowed to free flow.No backflow was observed.The customer complaint that the tubing had allowed backflow of blood when in use could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for the model lot number was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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 40 inch ext w/2 vlv ports allowed backflow of blood.The following information was provided by the initial reporter: "on friday, july 9, i received a call from anesthsia about iv tubing that had allowed blood to back up and come out of one of the access ports.".

• Brand Name: 40 INCH EXT W/2 VLV PORTS
• 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: 12294186
• MDR Text Key: 265596400
• Report Number: 9616066-2021-51739
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403235205
• UDI-Public: 50885403235205
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2023
• Device Model Number: 30263E
• Device Catalogue Number: 30263E
• Device Lot Number: 20099520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Date Manufacturer Received: 07/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2020
• 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