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

Model Number 40000-07T

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

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

Event Date 10/26/2021

Event Type  malfunction  

Event Description

It was reported that 2 bd alaris texium secondary sets experienced component separation.The following information was provided by the initial reporter: tubing came apart below drip chamber.

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/16/2021.H.6.Investigation: two samples were received and the customer's complaint of separation was immediately noticed.This verified the complaint.The sets were then visually analyzed under microscope to determine possible root cause - which was found to be a lack of solvent at the tubing- drip chamber junction during production.The manufacturing team has been made aware of this issue and have implemented changes to the production of this set in effort to eliminate further occurrences of this failure.Capa#3974230 was initiated.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 build of this set.A complaint history check was performed and this is the (b)(6) related complaint reported with the defect/condition of separation with lot #20095693, regarding item #40000-07t.

Event Description

It was reported that 2 bd alaris texium secondary sets experienced component separation.The following information was provided by the initial reporter: tubing came apart below drip chamber.

• Brand Name: BD ALARIS TEXIUM 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12916287
• MDR Text Key: 284987915
• Report Number: 9616066-2021-52524
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403225626
• UDI-Public: 50885403225626
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K790582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/08/2023
• 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: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/02/2020
• 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