MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD TEXIUM NEEDLE-FREE SYRINGE, 3 ML; PISTON SYRINGE

Catalog Number	MY8003
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Address was not located and il was used.Investigation summary: no product or photo was returned by the customer.The customer complaint of loose component - leak could not be verified due to the product not being returned for failure investigation.A device history record review for material# my8003 and lot# 24036107 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 25mar2024.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 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.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
Event or Problem Description
Material #:my8003, batch#:24036107.It was reported that the bd texium needle-free syringe, 3 ml was loose resulting in leak.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.Patient was receiving velcade injection.Towards the end of the injection about 3 drops of medication came from the texium cap, between the cap and the needle connection.Needle would not screw on any tighter and was on straight.Item -my8003, lot -24036107.

• Brand Name: BD TEXIUM NEEDLE-FREE SYRINGE, 3 ML
• Common Device Name: PISTON SYRINGE
• 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: 21118703
• Report Number: 9616066-2024-02222
• Device Sequence Number: 7463261
• Product Code: FMF
• UDI-Device Identifier: 10885403221651
• UDI-Public: (01)10885403221651(11)240325(17)270325(10)24036107
• 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
• Report Date (Section B): 12/24/2024

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: Health Professional
• Device Catalogue Number: MY8003
• Device Lot Number: 24036107
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown