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 Codes	Separation Failure (2547); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd alaris texium secondary set had components separate.The following information was provided by the initial reporter: " 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.
Event or Problem Description
It was reported that bd alaris texium secondary set had components separate.The following information was provided by the initial reporter: " it was reported that the tubing came apart when removing tubing from packages.".
Additional Manufacturer Narrative
H.6.Investigation: one sample was received for quality investigation.The customer complaint of separation other component - no leak was verified by visual inspection.Visual inspection of the sample received showed that the tubing had separated from the drip chamber.Further examination under magnification showed that there was a lack of adhesive at the drip changer and tubing joining location.A device history record review for model 40000-07t lot number 20095694 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A trend for the misassembly issue has been identified for this product line.The appropriate personnel have been notified of this complaint.We have funded a project, capa#33974230, to examine how to prevent future occurrences of this type.A complaint history check was performed and this is the 10th related complaint reported with the defect/condition of separation other component - no leak with lot #20095694 regarding item #40000-07t.H3 other text : see h.10.

• 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: 12960055
• Report Number: 9616066-2021-52551
• Device Sequence Number: 19270218
• 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,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: 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: 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: 12/08/2021
• Supplement Report FDA Received Date: 01/13/2022
• 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