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
Medical Device Problem Codes	Separation Failure (2547); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/22/2021.H.6.Investigation: two samples were submitted for quality investigation.The customer complaint of separation - no leak, was verified by visual inspection.The samples submitted were visually examined and the separation of the secondary sets were noted at the outlet of the drip chambers to the tubing.Further evaluation was conducted under magnification and there is no evidence of solvent on the joining components.A device history record review for model 40000-07t lot number 20095693 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the failure seen in this complaint is that there is a lack of solvent between the drip chamber outlet and the connecting tubing, therefore causing the secondary set to easily separate at that location.This is an issue caused during the manufacturing of the secondary set.Capa#1521069 was initiated.A complaint history check was performed and this is the 7th related complaint reported with the defect/condition of separation other component - no leak with lot #20095693 regarding item #40000-07t.H3 other text : see h.10.
Event or Problem 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.

• Brand Name: SEC 20DP, TEXIUM & HANGER V/NV
• Common Device Name: 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
• Report Number: 9616066-2021-52575
• Device Sequence Number: 4715610
• Product Code: FPA
• UDI-Device Identifier: 50885403225626
• UDI-Public: 50885403225626
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2022

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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 Sex: Unknown