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

Catalog Number	MY8030
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
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
It was reported that bd texium needle-free syringe had foreign matter the following information was received by the initial reporter with the following verbatim the xxx was using the syringe to draw up a dose of carboplatin.During this step, the technician noticed an imprint on the inside of the syringe barrel that resembled that of a fingerprint.The technician stopped using the syringe and used a new one to complete the dose for a patient.
Additional Manufacturer Narrative
It was reported that there was a fingerprint on the syringe.One sample model my8030, lot 23085585 was returned for investigation by the customer.The set was examined for defects and abnormalities.A fingerprint was seen on the syringe.No other defects or abnormalities were observed.The customer complaint was verified and a quality notification was sent to the manufacturer.From the manufacturer's investigation, the place of origin cannot be determined.Surgical gloves are warn 100% of the time while handling the product.A device history record review for model my8030 lot number 23085585 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 24aug2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
Event or Problem Description
No additional information.

• 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: 20723660
• Report Number: 9616066-2024-01678
• Device Sequence Number: 17106578
• Product Code: FPA
• UDI-Device Identifier: 10885403230523
• UDI-Public: (01)10885403230523(11)230824(17)260824(10)23085585
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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 Expiration Date: 08/24/2026
• Device Catalogue Number: MY8030
• Device Lot Number: 23085585
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown