MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD TEXIUM NEEDLE-FREE SYRINGE 30ML

Catalog Number	MY8030
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
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
Material # my8030 lot # 23115070 it was reported that the bd texium needle-free syringe 30ml contained foreign matter.The following information was provided by the initial reporter: "a pharmacy technician discovered a particle within the barrel and plunger prior to using the texium syringe." verbatim: rcc received a complaint via email.Email(s) attached we are reporting a quality issue that occurred yesterday, 4/18/2024.¿ texium 30 ml needle-free syringe / catalog number my8030 ¿ lot number 23115070 ¿ any injuries and/or harm? no ¿ what is the issue you experienced? a pharmacy technician discovered a particle within the barrel and plunger prior to using the texium syringe.¿ is the actual sample or sample representative available? (if possible, please send affected sample) yes.
Additional Manufacturer Narrative
The customer reported foreign substance in the syringe barrel, and returned one sample of material my8030, lot 23115070.Upon visual examination, the report was verified and an orange colored substance was stuck to the inside syringe plunger.The orange substance was investigated under a ftir machine in order to find out the chemical make-up of the substance.The findings did not help with identifying the root cause.The producer of the set, bd columbus, ne, was unable to trace the issue to manufacturing process.This was the first time seeing the issue, and it will continue to be monitored.Device history record review for model my8030 lot number 23115070 was performed.The search showed that a total of (b)(4) units in (b)(4) lot number was built on 03nov2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.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
No additional information was provided.

• Brand Name: BD TEXIUM NEEDLE-FREE SYRINGE 30ML
• Common Device Name: 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: 19312088
• Report Number: 9616066-2024-00747
• Device Sequence Number: 3077231
• Product Code: FMF
• UDI-Device Identifier: 10885403230523
• UDI-Public: (01)10885403230523
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: MY8030
• Device Lot Number: 23115070
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 05/14/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown