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	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris texium secondary set experienced separation with leakage.The following information was provided by the initial reporter: tubing came apart below the drip chamber while in use.
Event or Problem Description
It was reported that the bd alaris texium secondary set experienced separation with leakage.The following information was provided by the initial reporter: tubing came apart below the drip chamber while in use.
Additional Manufacturer Narrative
H.6.Investigation summary: no product or photo was returned by the customer.The customer complaint of drip chamber separation could not be verified due to the product not being returned for failure investigation.The sample was given to fedex by the customer, but there was an issue during the return of the sample and the sample was lost.The material and failure are something manufacturing is working toward addressing.There is a funded project at the plant level to mitigate the risk of solvent based separations recurring.Device history record review for model 40000-07t lot number 22029697 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 16feb2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Device history record review for model 40000-07t lot number 22049007 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 05apr2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• 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: 15341441
• Report Number: 9616066-2022-01266
• Device Sequence Number: 5037935
• 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): 10/07/2022

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 Model Number: 40000-07T
• Device Catalogue Number: 40000-07T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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