MAUDE Adverse Event Report: BECTON DICKINSON TEXIUM NEEDLE-FREE SYRINGE, 20 ML; SYRINGE, PISTON

Catalog Number	MY8020
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material: my8020; batch#: 24035566.It was reported by the customer that contamination in neck of syringe of this ¿sterile¿ product verbatim: rcc received a complaint via email.Event number 8: date of event: unsure.Material / lot # my8020 lot 24035566.Patient harm, injury, complication, negative outcome contamination in neck of syringe of this ¿sterile¿ product.
Additional Manufacturer Narrative
The customer reported foreign matter on the syringe, and returned one sample of material my8020, lot 24035566.Upon initial visual examination, the set verified the failure, and a yellowish crusty substance was on the inside of the syringe, also on the black rubber of the plunger.The foreign substance was analyzed using an ftir, but no chemicals or substances had a substantial match, and the matter could not be determined.Device history record review for model my8020 lot number 24035566 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: TEXIUM NEEDLE-FREE SYRINGE, 20 ML
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 20873769
• Report Number: 9616066-2024-01917
• Device Sequence Number: 15626776
• Product Code: FMF
• UDI-Device Identifier: 10885403221682
• UDI-Public: (01)10885403221682(11)240305(17)270305(10)24035566
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 05/14/2025

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: Health Professional
• Device Catalogue Number: MY8020
• Device Lot Number: 24035566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 12/07/2024
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown