MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD TEXIUM NEEDLE-FREE SYRINGE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MY8030
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: no product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.The customer provided the lot # available from the stock as 24026388 and dhr has been performed for the same.A device history record review for material# my8030 and lot#92233602 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02dec2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.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
No additional information.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd texium needle-free syringe was damaged.The following information was received by the initial reporter with the following verbatim.I am writing to formally address a serious concern regarding the performance of the texium closed system tubing we have been using in our chemotherapy administration.We have experienced multiple occurrences of leakage from the tubing, which has not only compromised the integrity of our chemotherapy protocols but has also posed significant safety risks to our staff and patients.Specifically, we have documented four instances where leakage occurred during chemotherapy infusions, necessitating the activation of our hazardous materials team to clean contaminated areas.This process is not only disruptive but also increases the potential for exposure to hazardous substances, which is unacceptable in a clinical setting.Additionally, we encountered a critical incident where the texium adapter broke while a nurse was attempting to attach it to a patient's iv port.This situation not only delayed treatment but also put the patient at risk and caused considerable distress among our staff.For your review, i have attached a video documenting one of the leakage incidents, which further illustrates the gravity of this issue.Given the importance of safety in chemotherapy administration, we urge your immediate attention to this matter.We expect a thorough investigation into the quality control measures for the texium closed system tubing and a prompt response regarding how you intend to address these defects.Thank you for your attention to this urgent matter.We look forward to your prompt response.Texium 30 ml syringe lot # 92233602.

• Brand Name: BD TEXIUM NEEDLE-FREE SYRINGE
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20700733
• Report Number: 9616066-2024-01668
• Device Sequence Number: 17082930
• Product Code: FPA
• UDI-Device Identifier: 10885403230523
• UDI-Public: (01)10885403230523(11)230201(17)251202(10)92233602
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K231888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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: 12/02/2025
• Device Catalogue Number: MY8030
• Device Lot Number: 92233602
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown