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); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ texium¿ secondary set tubing separated from below the drip chamber.The following information was provided by the initial reporter: "tubing came apart below drip chamber".
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation: the customer reported the tubing came apart at the drip chamber and returned one used sample of material #(b)(4).The sample was clearly separated below the drip chamber and the complaint is verified.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 is determined to be insufficient solvent.Our manufacturing team is aware of the issue and has funded a project, capa#3974230, to make the necessary changes.The solvent dispenser on the drip chamber assembly for multiple part numbers was found to have an issue with the screw depth specification and the issue is being addressed.A complaint history check was performed and this is the 2nd related complaint reported with the defect/condition of separation other component - no leak with lot #20095693 regarding item #40000-07t.
Event or Problem Description
It was reported that the bd alaris¿ texium¿ secondary set tubing separated from below the drip chamber.The following information was provided by the initial reporter: "tubing came apart below drip chamber".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12853538
• Report Number: 9616066-2021-52456
• Device Sequence Number: 3993012
• 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): 12/09/2021

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: 20095693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 12/09/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 12/30/2021
• 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