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

Model Number	40000-07T
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one sample was received for quality investigation.The customer complaint of separation other component - no leak was verified by visual inspection.Examination of the received sample indicated that the sample separated at the union between the outlet of the drip chamber and the tubing of the set.A device history record review could not be performed because the lot number is unknown.The root cause for the failure seen in this complaint is the lack of solvent seen at the junction point between the drip chamber and infusion set tubing.This issue has been previously identified and a quality investigation is being conducted in order to correct the issue.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 or Problem Description
It was reported that the bd alaris¿ texium¿ secondary set came apart while priming it.The following information was provided by the initial reporter: "came apart during priming¿.No fluid, no adverse event.".
Additional Manufacturer Narrative
Investigation summary: one sample was received for quality investigation.The customer complaint of separation other component - no leak was verified by visual inspection.Examination of the received sample indicated that the sample separated at the union between the outlet of the drip chamber and the tubing of the set.A device history record review could not be performed because the lot number is unknown.The root cause for the failure seen in this complaint is the lack of solvent seen at the junction point between the drip chamber and infusion set tubing.This issue has been previously identified and a quality investigation is being conducted in order to correct the issue.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 or Problem Description
It was reported that the bd alaris¿ texium¿ secondary set came apart while priming it.The following information was provided by the initial reporter: "came apart during priming¿.No fluid, no adverse event.".

• Brand Name: BD ALARIS¿ TEXIUM¿ SECONDARY SET
• 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: 13052376
• Report Number: 9616066-2021-52624
• Device Sequence Number: 1427236
• Product Code: FPA
• UDI-Device Identifier: 50885403225626
• UDI-Public: 50885403225626
• Combination Product (Y/N): N
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/29/2021

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: Other
• Device Expiration Date: 09/08/2023
• Device Model Number: 40000-07T
• Device Catalogue Number: 40000-07T
• Device Lot Number: 20095694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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