MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEC 20DP, TEXIUM & HANGER V/NV INTRAVASCULAR ADMINISTRATION SET

Model Number 40000-07T

Device Problems Separation Failure (2547); Separation Problem (4043)

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

Event Date 11/08/2021

Event Type  malfunction  

Event Description

It was reported 2 bd sec 20dp, texium & hanger v/nv experienced separation with no leakage the following information was provided by the initial reporter: separation other component- no leak, when tubing removed from package it was reported that the tubing came apart when removing tubing from packages.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete. Upon completion, a supplemental report will be filed. Medical device expiration date: unknown. Device manufacture date: unknown.

• Brand Name: SEC 20DP, TEXIUM & HANGER V/NV
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12980256
• MDR Text Key: 285339847
• Report Number: 9616066-2021-52575
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403225626
• UDI-Public: 50885403225626
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 40000-07T
• Device Catalogue Number: 40000-07T
• Device Lot Number: 20095693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial