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

Model Number 20019E

Device Problems Leak/Splash (1354); Material Deformation (2976)

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

Event Date 07/12/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one photo was submitted for quality investigation.The customer complaint of component damage - leak, the failure reported could not be verified.The tubing does appear to be kinked at the location indicated in the picture, however, it cannot be determined if this kink can be massaged out due to the physical sample not being submitted.A device history record review for the model and 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.Due to no physical sample being received, an 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 y ext w/vlv ports & 2 sld clp had kinked tubing and leaked.The following information was provided by the initial reporter: "plastic tubing was damaged prior to use, the tubing appears crimped or possibly melted and there was a hole in so when the rn placed on her iv site and tried to draw from it, blood came out the extension tubing instead of in to the lab tube.".

• Brand Name: Y EXT W/VLV PORTS & 2 SLD CLP
• 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: 12425945
• MDR Text Key: 269906945
• Report Number: 9616066-2021-51969
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 27613203013813
• UDI-Public: 27613203013813
• Combination Product (y/n): N
• PMA/PMN Number: K061285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/20/2024
• Device Model Number: 20019E
• Device Catalogue Number: 20019E
• Device Lot Number: 21026324
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2021
• 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