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

Catalog Number	MY8020
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
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#: 24055856.It was reported by the customer that while rn (registered nurse) was pushing sq (subcutaneous) injection the connection between the chemo cap and needle (25g 5/8") was showing noticeable leaking (approximately 4 drops).Verbatim: rcc received a complaint via email.Email(s) attached.While rn (registered nurse) was pushing sq (subcutaneous) injection the connection between the chemo cap and needle (25g 5/8") was showing noticeable leaking (approximately 4 drops).
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
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.A device history record review for material# my8020 and lot# 24055856 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 27may2024.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.

• 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: 20853385
• Report Number: 9616066-2024-01872
• Device Sequence Number: 7984572
• Product Code: FMF
• UDI-Device Identifier: 10885403221682
• UDI-Public: (01)10885403221682(11)240527(17)270527(10)24055856
• 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: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• 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: MY8020
• Device Lot Number: 24055856
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: 12/24/2024
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 12/30/2024
• 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: Female
• Patient Weight: 59 KG