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

Catalog Number	MY8020
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd texium needle-free syringe was leaking the following information was received by the initial reporter with the following verbatim it was reported by the customer that nurse administering iv push idarubicin 25.3mg at bedside.Idarubicin came in syringe with bonded texium closed system transfer device.Per protocol, nurse added primary line of normal saline and added texium to distal end of primary tubing and attached to patient's central line.Idarubicin pushed at lower y of primary tubing.About 10 minutes into push with 13.5ml remaining, nurse noticed leakage from texium at syringe.Infusion stopped; nurse noticed a drip on patient's skin.Cleansed with soap and water.Also, when nurse went to disconnect primary tubing from central line, there was a drop of fluid at the distal end of the texium upon disconnection.Leadership and pharmacy notified.Nurse transported chemo and tubing in double chemo bag back to pharmacy to obtain new syringe.Item # (b) (4) note: return to manufacturer has been requested and this is in process.Recurrent issues noted with texium.Leaking for size 50 with lots 24055854, also leaked when shooting into iv bag.Leaking for size 30 texium with lots which even leaked when double female to another syringe.Leaking for size 20 texium with lots.
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
No additional information.
Additional Manufacturer Narrative
It was reported by the customer that the product was leaking at the texium connector.One photo was received for quality evaluation.Inspection of the photo shows a syringe with a texium connector attached to the syringe.The photo does not show the leakage reported by the customer.The customer complaint of leakage could not be confirmed.Based on the physical sample not being provided, a root cause for this issue could not be fully determined, although we could not confirm the reported failure, a trend has been identified and actions have been initiated to investigate the issue.Corrective actions taken during this investigation will be implemented in our production process to further increase the robustness and reliability of the device and prevent future occurrences of this type.A device history record review for model my8020 lot number 24066952 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• 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: 21022123
• Report Number: 9616066-2024-02133
• Device Sequence Number: 13050344
• Product Code: FPA
• UDI-Device Identifier: 10885403221682
• UDI-Public: (01)10885403221682(11)240527(17)270527(10)24055856
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K231888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2025

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 Catalogue Number: MY8020
• Device Lot Number: 24055856
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown